I-CAR T-Cell Therapy E-China
Uhlela ukuvakashela eChina ukuze uthole ukwelashwa kwe-CAR T?
Thola isilinganiso ezibhedlela eziphezulu e-China.
I-innovative immunotherapy ebizwa nge-CAR T-cell treatment ibone ukukhula okukhulu emphakathini wezokwelapha waseChina. I-CAR T Cell therapy eShayina ithuthuka ngokuphawulekayo futhi inamandla okuguqula ukwelashwa komdlavuza. I-China manje isiyingqalabutho kule mboni ngenxa yohlaka lwayo oluqinile lokulawula nengqalasizinda yocwaningo, okuye kwabhebhezela intuthuko yayo. Ukwelashwa kwe-CAR T-cell kuye kwathuthukiswa ngempumelelo yizinkampani ezimbalwa zaseShayina ze-biopharmaceutical, okubonisa imiphumela ekhuthazayo ezigulini ezine-hematological malignancies. Ngaphezu kwalokho, inani elikhulu leziguli zaseChina linikeza inzuzo ekhethekile yokwenziwa izivivinyo zokwelashwa kanye nokuhlanganisa idatha. Imizamo yaseChina inomthelela ekusaseni le imithi eqondile kanye nokunikeza ithemba elisha ezigulini ezinomdlavuza emhlabeni wonke njengoba ukwelashwa kwe-CAR T-cell kuqhubeka.
Yini Eyenza I-CAR T Cell Therapy E-China Ikhetheke Kangaka?
Ukwelashwa kwe-CAR T-cell eChina kuyintuthuko enkulu ekwelapheni umdlavuza, kunikeze iziguli ebezinezinketho ezimbalwa ngaphambili, ithemba elisha. Lokhu kwelashwa okusha sekuzuze ukuvelela e-China, lapho izinhlolo zokwelashwa eziqhubekayo ezingaphezu kuka-700 zihlola izindlela zokuthuthukisa ukusebenza kahle nokuphepha kwakho.
I-China iye yavela njengephayona kulo mkhakha, ikhombisa ukuzinikela okuqinile ocwaningweni lwezokwelapha nokunakekelwa kweziguli okuthuthukile. Isayensi ngemuva kokwelashwa kwe-CAR T Cell yomdlavuza eChina ibandakanya ukuguqula amaseli omzimba esiguli ukuze abone futhi ahlasele amaseli omdlavuza. Lokhu kufezwa ngobunjiniyela bezakhi zofuzo, lapho ama-T cell esiguli afakwe i-chimeric antigen receptor (CAR) eqondise amaprotheni aqondene nomdlavuza. Ama-T cell akhishwa esigulini, ashintshwe izakhi zofuzo elabhorethri, abese ebuyiselwa emzimbeni wesiguli ukuze ahlasele umdlavuza.
Ukwelashwa kwe-CAR T cell yomdlavuza e-china kuye kwaphumelela ekwelapheni izinhlobo ezihlukahlukene zomdlavuza, futhi ucwaningo oluqhubekayo luyaqhubeka nokucwenga nokwandisa ukusebenza kwalo. Ngezinhlelo zokusebenza zezentengiso ezifana ne-Yescarta ne-Relma-cel, ikusasa lokwelashwa kwe-CAR T-cell e-China liqhakazile, ngokukhula okukhulu kwemakethe okulindelwe futhi abadlali basekhaya abenza impumelelo enkulu. Uhambo olusuka ezivivinyweni zemitholampilo luye kwezinhlelo zokusebenza zezentengiselwano lubonisa ukuzinikela ekuthuthukiseni isayensi yezokwelapha ukuze kuzuze iziguli ezinomdlavuza eChina.
I-CAR T Cell Therapy E-China Idlula I-U.S. Ezixazululweni Zomdlavuza!
I-China Ibusa Kanjani Izilingo Zomtholampilo?
Kusukela ngoJanuwari 2024, kunezilingo zomtholampilo ezingaphezu kuka-700 okwamanje eziqhubekayo ezibhedlela ezihlukahlukene e-China ezigxile ekuthuthukisweni kokwelashwa kwe-CAR T Cell. Kusukela ngo-2017 uhulumeni waseShayina utshale imali eningi endaweni ye-biotechnology, futhi imiphumela mikhulu kakhulu. I-China iqhamuke njengesikhungo esinamandla okucwaninga umdlavuza, ikakhulukazi emkhakheni we-CAR-T cell therapy yomdlavuza eChina. Lezi zifundo zomtholampilo, ezenziwe izikhungo ezihlonishwayo, zenza inqubekelaphambili ebonakalayo ekwelapheni izinhlobo ezahlukene zomdlavuza. I-CAR T cell therapy ye-leukemia e-China, I-CAR T Cell Therapy ye-lymphoma futhi Isekelwe ku-BCMA I-CAR T Cell therapy ye-myeloma eminingi e-China ezinye izinhlobo ezinkulu ezithola izimpendulo ezinhle ezivivinyweni.
Isibonelo, iSibhedlela Somdlavuza sase-Peking University e-Beijing, e-China sibonise imiphumela emihle kakhulu ekwelapheni i-acute lymphoblastic leukemia (YONKE) ebuyele emuva noma eqinile ngamaseli e-CAR-T, okuhlinzeka ngomzila wokuphila ezigulini ezinezinketho ezilinganiselwe.
Ukugxila akukhona nje kumdlavuza wegazi; I-China iphinde ibheke ekwelashweni kwamaseli e-CAR-T ngamathumba aqinile, obekunzima ukuwelapha phambilini. Ukuze unqobe izimo ezinzima zokucindezelwa kwamasosha omzimba ezikhona kumathumba, kusetshenziswa amasu ahlakaniphile ukuze kuthuthukiswe ukusebenza kahle kwamaseli e-CAR-T.
Ukusebenzisana kwamazwe ngamazwe kudlala indima ebalulekile empumelelweni yaseShayina, nabacwaningi baseShayina babambisana emhlabeni wonke ukushintshanisa ubungcweti. Lesi sinyathelo singashintsha i-CAR T e-China, sinikeze enye indlela elula nengabizi.
Iyini Ububanzi Bokwelashwa Kwe-CAR-T E-China?
Ukusetshenziswa kwe-chimeric antigen receptor (CAR) T-cell zokwelapha ekwelapheni i-hematological malignancies kuye kwasebenza ngendlela emangalisayo. Ukusetshenziswa kokwelashwa kwe-CAR T-cell kukhule e-China eminyakeni eyisishiyagalolunye edlule.
Izifundo zokuqala zomtholampilo ze-CAR T cell zaqala ngo-2013, futhi ngo-2017 kwase kunezinhlolo zomtholampilo zamaseli e-CAR T amaningi kunangaphambili. Kungekudala ngemuva kwalokho, iChina yamemezela ukuthi izohlinzeka ngemali eyizigidi eziyizinkulungwane ezingama-US $237 yokuxhasa amabhizinisi okwelapha amangqamuzana ngo-2021, okwakumele ukwanda okukhulu kwenani lezivivinyo zemitholampilo kanye namaphrojekthi ocwaningo ayisisekelo afaka amaseli e-CAR T.
Ukwesekwa okuqinile kukahulumeni, ukungena kwemali, isidingo esikhulu seziguli, uhlelo lokunakekelwa kwezempilo oluhlukile, nemizamo yodokotela nososayensi baseShayina konke kube nomthelela kulokhu kukhula okuphawulekayo komsebenzi eChina.
Inqubo yokwelashwa kwe-CAR T-Cell
I-CAR T Cell Therapy ye-myeloma eminingi e-China, kanye nezinye izinhlobo zomdlavuza wegazi, kuwuhlobo lokwelapha okuthuthukisiwe okuhlanganisa nokuhlela kabusha amangqamuzana omzimba esiguli ukuze aqondise futhi aqede amangqamuzana omdlavuza. Inqubo ye-CAR T cell ngokuvamile ibandakanya izinyathelo ezimbalwa ezibalulekile:
Ukuqoqwa Kweseli (Apheresis):
Umkhuba wokuqoqa ama-T cell esiguli, uhlobo lwamangqamuzana omzimba omzimba, lwaziwa ngokuthi i-apheresis. Phakathi ne-apheresis, igazi liqoqwa esigulini bese umshini uhlukanisa ama-T cell. Igazi elisele libe selibuyiselwa emzimbeni wesiguli. Ama-T cell aqoqwa egazini kusetshenziswa ishubhu elifakwe emthanjeni wengalo. Lokhu kuthatha amahora ambalwa.
Ukuguqulwa Kwezakhi Zofuzo:
Amaseli e-T ashintshwa ngofuzo elebhu ukuze aveze i-Chimeric Antigen Receptor (CAR) endaweni yawo. I-CAR ihlelelwe ukubona amaprotheni athile, noma ama-antigen, atholakala ebusweni bamaseli omdlavuza.
Ukwandiswa kwamaseli:
Khona-ke ama-T cell ashintshwe ngofuzo ayatshalwa futhi aphindaphindeke, okuholela ekubeni kube nenani elikhulu lamaseli e-CAR T. Le nqubo iqinisekisa ukuthi kunama-T cell anele aguquliwe afinyelelekayo ukuze uthole ukwelashwa okuphumelelayo.
I-Conditioning (i-Lymphodepletion):
Iziguli zivame ukuphathwa ngaphansi kokwelashwa kwe-conditioning ngaphambi kokumnika i-CAR T-cell, okungase kuhlanganise umthamo ophansi we-chemotherapy noma imisebe. Lokhu kulungisa kusiza ekwakheni indawo lapho amaseli e-CAR T asanda kufakwa akwazi ukuziphindaphinda futhi asebenze ngaphakathi komzimba wesiguli.
Ukufakwa kwe-CAR T-Cells:
Uma eselungisiwe, amaseli e-CAR T aphinde ajovwe abuyele egazini lesiguli nge-drip. Amaseli e-CAR T afakiwe abe esejikeleza umzimba wonke, efuna futhi ebopha kumaseli omdlavuza aveza i-antigen ehlosiwe.
Ukukhomba Nokubulala Amaseli Omdlavuza:
Lapho i-CAR T cell ihlangana nengqamuzana lomdlavuza eliqukethe i-antigen efanelekile, libopha ingqamuzana lomdlavuza. Lokhu kusebenzisana kwenza i-CAR T cell isebenze, iyenze ikhulule ama-molecule abulala ingqamuzana lomdlavuza.
Ukuqapha Impendulo:
Iziguli ziqashwe ngeso elibukhali ukuze kutholakale noma yiziphi izimpawu zokusabela, okuhlanganisa nokuncipha kobukhulu bamathumba. Impumelelo yokwelashwa kwe-CAR T-cell ihlolwa kusetshenziswa izinhlobonhlobo zokuthwebula izithombe kanye nokuhlolwa kwelabhorethri.
Ukuphatha imiphumela emibi:
Ezinye iziguli zingase zibe ne-cytokine release syndrome (CRS) noma i-neurotoxicity, eqashwe eduze ochwepheshe bezempilo.
Ungasifaka Kanjani Isicelo Sokwelashwa Kwe-CAR T-Cell E-China?
Thumela imibiko yakho
Send the following reports which includes Medical summary, Latest blood reports, Biopsy, Latest PET Scan, Bone marrow biopsy (If available) to info@cancerfax.com or WhatsApp them at +1-213 789-56-55
Ukuhlola Nombono
Uma ithimba lethu seliyitholile imibiko yakho yezokwelashwa, siyayihlaziya futhi siyithumele ezibhedlela ezenza i-CAR T-Cell therapy ngalolo hlobo lomdlavuza nomaka. Sithumela imibiko kuchwepheshe othintekayo futhi sithole umbono wakhe. Siphinde sithole izilinganiso ezivela esibhedlela ngokwelashwa okuphelele.
I-visa yezokwelapha kanye nokuhamba
Uma usunqume ukuvakashela ukwelashwa, sihlela incwadi ye-visa yezokwelapha kanye neminye imibhalo edingekayo evela esibhedlela. Uma i-visa isilungile siyakusiza futhi sikuqondise ekulungiseleleni amathikithi ohambo nendiza.
Ukwelashwa nokulandelela
Ummeleli wethu uzohlela ukuqokwa kukadokotela futhi agcwalise izinqubo ezidingekayo zokubhalisa kuwe. Uzokusiza futhi ngokulaliswa kwakho esibhedlela kanye nolunye usizo lwendawo nokwesekwa okudingekayo. Ngemva kokuphela kokwelashwa sizohlela ukuthi ulandelele ukubonisana nodokotela owelaphayo.
Kungani I-China Iyindlela Engcono Kakhulu?
Izivivinyo Zemitholampilo Nocwaningo Oluthuthukile
Ngokuqhubeka kokuhlolwa kwemitholampilo engaphezu kuka-700 ku-CAR T-Cell ukwelashwa komdlavuza e-China kuzuze intuthuko enkulu. Izindlela zokwelapha ezintsha ze-CAR T-cell zithuthukiswe futhi zahlolwa abacwaningi baseShayina nezikhungo zezokwelapha, ngokugxila kuzo zombili izimila eziqinile kanye nezifo ze-hematological. Mayelana nentuthuko yokwelashwa kwamaseli e-CAR T, i-China ibihamba phambili, futhi izivivinyo eziningi zomtholampilo ezisezingeni eliphezulu zenzeka lapho. Ngenxa yalokhu, iziguli ezifuna ukufinyelela ekuthuthukisweni kwakamuva kakhulu kwe-CAR T cell therapy zingase zithole i-China njengendlela ekhangayo.
Izindleko Nokutholakala
Izindleko zokwelashwa kwe-CAR T-Cell e-China ziphansi kakhulu kunalezo zamazwe afana ne-US, UK, Australia, JapaneKorea, naseSingapore. Ukwelashwa kwe-CAR T-Cell e-China kungabiza u-$60,000 nje kuphela. I-China inokutholakala okuphezulu ngokuqhathaniswa kwe-CAR T cell therapy yomdlavuza e-China. Kungase kube nezikhathi zokulinda ezimfushane zokwelashwa manje njengoba izikhungo zezokwelapha ezengeziwe e-China zithole ukugunyazwa okungokomthetho ukuhlinzeka ngokwelashwa kwamaseli e-CAR T. Ngaphezu kwalokho, ukwelashwa kwe-CAR T cell kuvame ukubiza kancane e-China kunakwezinye izindawo, njengase-United States. Le nto ingase ibaluleke ikakhulukazi kubantu abafuna ukukhetha ukwelashwa okuthengekayo.
Ubungcweti Nesipiliyoni
Ngenxa yokubamba iqhaza kwayo ezivivinyweni eziningi zemitholampilo kanye nokwelapha, i-China isithuthukise isamba esibalulekile solwazi nolwazi ekuhlinzekeni nge-CAR T cell therapy ye-leukemia e-china Ochwepheshe bezokwelapha baseShayina bathuthukise ulwazi lwabo ngezinkinga ezihlobene nokwelashwa kwe-CAR T kanye nekhono labo zilawule ukuze zithuthukise imiphumela yesiguli. I-China inikeza ukunakekelwa kwezempilo okusezingeni eliphezulu ngenxa yeziguli zayo eziningi, ingqalasizinda esekelayo, nolwazi oluqoqiwe ekwelapheni kwamaseli e-CAR T omdlavuza eChina.
Izinkampani E-U.S. Zisebenzisana Nezinkampani ZaseShayina
Eminyakeni yakamuva, amabhizinisi aseMelika aqale ukusebenzisana nozakwabo baseShayina ukuthuthukisa imithi ye-CAR T cell. Okwesibonelo. Ngo-2015, i-WuXi AppTec, inhlangano yocwaningo lwenkontileka yase-China (CRO), kanye ne-Juno Therapeutics, ibhizinisi elizinze e-US le-biopharmaceutical, babambisane ngamasu. Inkampani yaseShayina ye-biopharmaceutical Cellular Biomedicine Group isebenze nenkampani yase-US biopharmaceutical Celgene, manje eseyingxenye yeBristol-Myers. Squibb. Ubambiswano lomhlaba jikelele kanye nesivumelwano selayisense senziwa phakathi kwe-Janssen Biotech, inkampani eyenza imithi kaJohnson & Johnson, kanye ne-Legend Biotech, ibhizinisi elisebenza e-China nase-US.
Odokotela Abaphezulu Be-CAR-T Therapy E-China
Thatha umbono wesibili wochwepheshe ngokufakwa kokwelashwa kwe-CAR T-Cell kubacwaningi abahamba phambili e-China.
Prof. Peihua Peggy Lu, (MD)
Umongameli Omkhulu Wezokwelapha wesibhedlela i-Lu Daopei, e-Beijing, e-China , Isipiliyoni: Iminyaka engama-27
Dr Zhao Defeng, (MD)
Director, Hematology Department , Beijing Gobroad Hospital, Experience: 24 Years
Dr. Zhao Defeng is the Director of the Hematology Department at Gaobo Medical (Hematology) Beijing Research Center, Beijing Gaobo Boren Hospital, specializing in general hematology in Ward Nine. He holds the position of Associate Chief Physician and has a Master’s degree from the Second Military Medical University. Dr. Defeng has experience with over 1000 patients administering CAR T-cell therapy and has more than 23 ongoing clinical trials on it. He is regarded as one of the best doctors for CAR T-cell therapy in China.
Izibhedlela Eziphezulu Zokwelashwa Kwe-CAR T E-China
Peking University Cancer Hospital
Indlela entsha yokwelapha amasosha omzimba eyaziwa ngokuthi i-CAR T-cell therapy ibonise isithembiso esiyingqayizivele ekwelapheni izifo ezihlukahlukene ezibulalayo. I-Beijing, isibhedlela somdlavuza sase-China sase-Peking University sesiphenduke umholi womhlaba wonke ekuthuthukisweni kokwelashwa kwe-CAR T-cell. Ngosizo lwethimba labo lezinhlaka eziningi, elihlanganisa ongoti be-oncologists, odokotela bamasosha omzimba, nezazi zofuzo, ukwelashwa komdlavuza okuqondene nomuntu kuthuthuke kakhulu. I-Peking University Cancer Hospital ithole imiphumela evelele ezigulini ezine-hematological malignancies ngokushintsha amaseli e-T eziguli ukuze aveze ama-chimeric antigen receptors (CARs). Lokhu kwelashwa okuphambili kunikeza iziguli ezinomdlavuza ithemba elisha ngenkathi kushintsha umkhakha we-oncology futhi kukhuphula amazinga okusinda.
Isibhedlela saseBeijing Gobroad Boren
Uchwepheshe owaziwayo uneminyaka engamashumi amathathu yokuhlangenwe nakho okukhulu kwangaphakathi komtholampilo kanye nelabhorethri, egxile kakhulu esizindeni se-hematology. Umnyango uhlinzeka ngezinsiza eziningi zokuxilonga nokwelapha izifo ezithinta uhlelo lwe-hematological, njenge-multiple myeloma, i-leukemia, i-lymphoma, i-thalassemia, i-coagulation disorders, nezimila ze-hematological. Isebenza ngokukhethekile ezinhlelweni zokwelashwa komuntu ngamunye kanye nokuxilongwa okudidiyelwe kwezifo ze-hematological. Izinketho zokwelapha izimila ze-hematological zihlanganisa i-chemotherapy, i-immunotherapy, ukwelashwa okuhlosiwe, i-demethylation, ne-radiotherapy. Ngaphezu kwalokho, ukuze kuqinisekiswe ukuphepha nokusebenza ngempumelelo kokusetshenziswa kwemithi, abasebenzi bethu bezokwelapha ngokufanayo balungisa imithamo ngokuhambisana nezici ze-genotype ze-metabolism yezidakamizwa kanye nokuqapha ukugxila kwezidakamizwa.
Isibhedlela iLu-Daopei
I-Beijing, isibhedlela sase-China i-Lu Daopei sithuthuke kakhulu emkhakheni wokwelashwa kwe-CAR T-cell. Isibhedlela iLu Daopei, esibeka phambili ekwelapheni umdlavuza kanye nocwaningo, besihamba phambili ekusebenziseni i-CAR T-cell therapy ukwelapha izifo ze-hematological. Odokotela bezifo zomdlavuza, odokotela bamasosha omzimba, kanye nezazi zezakhi zofuzo eqenjini labo bazibophezele ekuqedeleni izivivinyo zomtholampilo nokudala ukwelashwa kwe-CAR T-cell okuqondene nesiguli. Isibhedlela i-Lu Daopei sibone intuthuko ekhuthazayo emiphumeleni yesiguli kanye namazinga okusinda ngenxa yolwazi lwaso nezinsiza ezisezingeni eliphezulu. Umsebenzi wabo uyaqhubeka nokuba nomthelela endleleni umdlavuza welashwa ngayo, uvulela amathuba amasha ezigulini ezidinga ithemba. Kuze kube manje, bathi benze ngaphezu kwe-1000 CAR T-Cell therapy infusions.
Isibhedlela Esihlanganisiwe Sokuqala, Isikole Sezokwelapha saseZhejiang University, e-Hangzhou
Isibhedlela Esihlangene Sokuqala, i-Zhejiang University School of Medicine yasungulwa ngo-1947. Isibhedlela sokuqala esihlangene sase-Zhejiang University, iqoqo lokuqala lezikhungo zokwakha izikhungo zezokwelapha zikazwelonke "ezisezingeni eliphezulu", Isikhungo Sikazwelonke Sezokwelapha Sezifo Ezithathelwanayo, Isikhungo Esiholayo. yokwakhiwa kweNational-Level Co
Isibhedlela Esihlanganisiwe Sokuqala, iwebhusayithi yeSikole Sezokwelapha saseZhejiang University
Isibhedlela Sokuqala Esihlanganisiwe saseYunivesithi yaseZhengzhou
Emkhakheni wokwelashwa kwe-CAR T-cell, Isibhedlela Sokuqala Esihlanganisiwe saseZhengzhou University, esiseZhengzhou, eChina, sesiyinhlangano eyaziwayo. Isibhedlela senze inqubekelaphambili enkulu ekwandiseni amandla e-CAR T-cell therapy ezigulini ngokugcizelela kakhulu ekwelashweni komdlavuza osezingeni eliphezulu. Ongoti bezempilo, odokotela bamasosha omzimba, izazi zezakhi zofuzo, kanye namanye amalungu ezisebenzi zabo zezokwelapha ezihlukene imikhakha eyahlukene bonke babambe iqhaza elibonakalayo ezifundweni nasezivivinyweni zokwelashwa. Lesi sikhungo selaphe izifo ze-hematological ngempumelelo emangalisayo ngenxa yokusebenzisa i-CAR T-cell therapy. Njengoba ukwelashwa komdlavuza komuntu siqu kukhula, Isibhedlela Sokuqala Esihlanganisiwe sase-Zhengzhou University sihamba phambili, sinikeza iziguli ithemba elisha kanye nezinga lempilo elingcono.
Izindleko zokwelashwa kwe-CAR T-Cell e-China
Ake sihlolisise izindleko I-CAR-T cell therapy e-China. Ngokuvamile isukela ku-$45,000 kuya ku-$80,000. Izindleko ze-FUCASO (BCMA based CAR T-Cell therapy for multiple myeloma) zibiza cishe u-$200,000 USD. Kodwa khumbula ukuthi lezi yizilinganiso nje ezilukhuni, futhi izindleko eziqondile zincike ezintweni ezimbalwa. Uhlobo lokwelapha nge-CAR-T, inkimbinkimbi yokwelashwa, izindleko zesibhedlela, ukunakekelwa okwengeziwe, nokuxilongwa kungathinta izindleko zokugcina. Khumbula ukuthi lezi zinombolo zingashintsha ngokuya ngesimo sakho sempilo. Ukusiza ukuphatha lezi zindleko, kufanele uxhumane nethimba lakho lezempilo. Bangakunikeza ulwazi lomuntu siqu. Kufanele futhi uhlole ukuze ubone ukuthi umshwalense wakho uyawufaka yini noma yiziphi izinhlelo zosizo lwezezimali ezikhona. Lokhu kukuvumela ukuthi wenze izinqumo ezingcono kakhulu zokwelashwa kwakho kanye nesabelomali sakho.
Iyini I-CAR T-Cell Therapy?
I-Chimeric antigen receptor T-cell therapy, evame ukwaziwa ngokuthi i-CAR T-cell therapy, iwukwelapha okugoqa phansi okushintshe ngokuphelele indlela yokwelapha umdlavuza. Inikeza iziguli ezinomdlavuza othile ithemba ebekade libhekwa njengengelapheki noma kunezinye izindlela zokwelapha ezimbalwa.
Ukwelashwa kuhlanganisa ukusebenzisa amaseli omzimba esiguli—ikakhulukazi, ama-T cell—kanye nokuwashintsha ilebhu ukuze kuthuthukiswe amandla awo okuthola nokucekela phansi amangqamuzana omdlavuza. Ukwenza lokhu, ama-T cell anikezwa i-chimeric antigen receptor (CAR), ewanikeza amandla okukhomba amaprotheni athile, noma ama-antigen, ebusweni bamaseli omdlavuza.
Ama-T cell esiguli aqale akhishwe, bese eshintshwa izakhi zofuzo ukuze aveze i-CAR. Elabhorethri, la mangqamuzana ashintshiwe ayaphindaphindeka ukuze akhiqize inani elikhulu lamaseli e-CAR T, abese ebuyiselwa egazini lesiguli.
Ngokushesha nje lapho engaphakathi emzimbeni, amaseli e-CAR T athola amangqamuzana omdlavuza aveza i-antigen oyifunayo, anamathisele kuwo, futhi aqalise ukusabela okunamandla kokuzivikela komzimba. Amaseli e-CAR T acushiwe ayanda futhi ahlasele amangqamuzana omdlavuza, awabulale.
Isebenza Kanjani I-CAR T-Cell Therapy?
Lapho isetshenziselwa ukwelapha izifo ezithile zegazi njenge-acute lymphoblastic leukemia (ALL) kanye nezinhlobo ezithile ze-lymphoma, ukwelashwa kwe-CAR T cell ye-lymphoma e-china kubonise imiphumela engavamile. Ikhiqize izilinganiso zokusabela eziphawulekayo futhi kwezinye iziguli, ngisho nokukhululwa okuhlala isikhathi eside.
I-CAR T-cell therapy, nokho, iyindlela yokwelapha eyinkimbinkimbi neyingqayizivele engase ibe nezingozi nemiphumela emibi. I-Cytokine release syndrome (CRS), ukusabela kwe-immunology okusabalele okungase kubangele izimpawu ezifana nomkhuhlane futhi, ezimweni ezimbi kakhulu, ukwehluleka kwezitho, kungase kutholwe abantu abathile. Kubuye kube nemibiko yemiphumela emibi yemizwa, nokho ivamise ukulapheka.
Naphezu kwalobu bunzima, ukwelashwa kwe-CAR T-cell kuyintuthuko ebalulekile ekulweni nomdlavuza futhi kukhombisa amandla amakhulu ekusasa. Ucwaningo lwamanje lugxile ekuthuthukiseni ukusebenza kwayo kanye nephrofayili yokuphepha kanye nokwelula ukusetshenziswa kwayo ezinhlotsheni zomdlavuza ezihlukene. Ukwelashwa kwe-CAR T-cell kungashintsha ubuso bokwelashwa komdlavuza futhi kunikeze iziguli yonke indawo ithemba elisha ngentuthuko eyengeziwe.
Lolu hlobo lokwelapha lubandakanya ukulungisa ama-T cell esiguli, uhlobo lwamangqamuzana omzimba omzimba, elebhu ukuze abophe futhi abulale amangqamuzana omdlavuza. Ishubhu lithutha igazi lisuka emthanjeni osengalweni yesiguli liye emshinini obizwa ngokuthi i-apheresis (ongabonisiwe), okhipha amangqamuzana amhlophe egazi, kuhlanganise nama-T cell, bese ubuyisela igazi elisele esigulini.
Amaseli e-T abe eseshintshwa ngofuzo elebhu ukuze aqukathe ufuzo lwesamukeli esiyingqayizivele eyaziwa ngokuthi i-chimeric antigen receptor (CAR). Amaseli e-CAR T aphindaphindeka elebhu ngaphambi kokuthi afakwe esigulini ngamanani amakhulu. I-antigen emangqamuzaneni omdlavuza ingabonwa ngamaseli e-CAR T, abese ebulala amangqamuzana omdlavuza.
Hlobo Luni Lomdlavuza Olungelashwa Nge-CAR-T Cell Therapy?
Iziguli kuphela ezine-B-cell non-lymphoma Hodgkin’s noma i-pediatric acute lymphoblastic leukemia esezizame izindlela ezimbili zokwelapha ezivamile ezingaphumelelanga okwamanje ezingasebenzisa imikhiqizo yokwelapha ye-CAR T-cell ethole imvume ye-FDA. Kodwa-ke, ukwelashwa kwe-CAR T-cell manje kuyahlolwa ezifundweni zomtholampilo njengokwelashwa komugqa wokuqala noma wesibili we-lymphoma yabantu abadala kanye ne-acute lymphoblastic leukemia yezingane. Muva nje, ezinye zezifundo zibonise impumelelo emangalisayo ezimeni zezimila eziqinile ezifana ne-glioblastoma, i-gliomas, umdlavuza wesibindi, umdlavuza wamaphaphu, umdlavuza we-GI, umdlavuza we-pancreatic, nomdlavuza womlomo.
Lokhu kubonisa intuthuko enkulu ekulawuleni i-leukemia kanye ne-B-cell lymphoma. Ukwengeza, kunikeza ithemba kulabo okwabikezelwa ukuthi ukuphila kwabo kuzohlala izinyanga eziyisithupha kuphela. Manje njengoba sesihlonze izindlela zokumelana futhi sakha amasu amaningi okulwa nazo, ikusasa libonakala lithembisa kakhulu.
Thintana nabahlinzeki bethu bezempilo abanolwazi olunzulu lapha ku ICancerFax ukuze uthole ukubonisana kwamahhala ukuze wenze uhlelo lokunakekelwa olufanele lwezidingo zakho zezempilo. Sicela uthumele imibiko yakho yezokwelashwa ku-info@cancerfax.com noma ku-WhatsApp ku- + 1 213 789 56 55.
Yiziphi Izinzuzo Ze-CAR-T Cell Therapy?
Inzuzo eyinhloko ukuthi ukwelashwa kwe-CAR T-cell kudinga kuphela ukumnika okukodwa futhi ngokuvamile kudinga kuphela amasonto amabili okunakekelwa kwesiguli. Iziguli ezine-non-Hodgkin lymphoma kanye ne-leukemia yezingane ezisanda kutholwa, ngakolunye uhlangothi, ngokuvamile zidinga imiphumela emibi yokwelashwa ngamakhemikhali okungenani izinyanga eziyisithupha noma ngaphezulu.
Izinzuzo zokwelashwa kwe-CAR T-cell, okuwumuthi ophilayo, kungaqhubeka iminyaka eminingi. Uma futhi kwenzeka ukuphindeka, amaseli azokwazi ukuhlonza futhi aqondise amaseli omdlavuza ngoba angaphila emzimbeni isikhathi eside.
Nakuba ulwazi lusathuthuka, u-42% weziguli ze-lymphoma zabantu abadala ezathola ukwelashwa kwe-CD19 CAR T-cell zazisenoshwele ngemva kwezinyanga eziyi-15. Futhi ngemva kwezinyanga eziyisithupha, izingxenye ezimbili kwezintathu zeziguli ezine-acute lymphoblastic leukemia zazisaxole. Ngeshwa, lezi ziguli zinezimila ezinolaka kakhulu ezingazange zilashwe ngempumelelo kusetshenziswa izindinganiso zendabuko zokunakekela.
Hlobo Luni Lweziguli Ezingaba Abamukeli Abakahle Be-CAR-T Cell Therapy?
Iziguli ezineminyaka ephakathi kweMinyaka emi-3 kuya kwengama-70 zizame ukwelashwa nge-CAR T-Cell ngezinhlobo ezahlukene zomdlavuza wegazi futhi kutholwe kusebenza kahle kakhulu. Izikhungo eziningi ziye zafuna amanani empumelelo angaphezu kuka-80%. Umuntu ongcono kakhulu wokwelashwa kwe-CAR T-cell ngalesi sikhathi yingane ene-acute lymphoblastic leukemia noma umuntu omdala one-B-cell lymphoma enamandla osevele enemigqa emibili yokwelapha okungasebenzi.
Ngaphambi kokuphela kuka-2017, lalingekho izinga elamukelekayo lokunakekela ezigulini esezidlule emigqeni emibili yokwelashwa ngaphandle kokuthola ukuxolelwa. Okuwukuphela kwendlela yokwelapha egunyazwe i-FDA kuze kube manje osekufakazele ukuthi kunenzuzo enkulu kulezi ziguli ukwelapha nge-CAR T-cell.
Isebenza Kangakanani I-CAR-T Cell Therapy?
Ukwelashwa kwe-CAR T-cell kube yimpumelelo kakhulu ekwelapheni ezinye izinhlobo zomdlavuza wegazi, njenge-acute lymphoblastic leukemia (ALL) kanye ne-non-Hodgkin lymphoma. Ezivivinyweni zemitholampilo, amazinga okuphendula abe mahle kakhulu, futhi iziguli eziningi ziye zangena ekwelashweni okuphelele. Kwezinye izimo, abantu ababezame yonke eminye imithi baba nokukhululwa okuhlala isikhathi eside noma ngisho nokwelashwa okungenzeka.
Enye yezinto ezinhle kakhulu ngokwelashwa kwe-CAR T-cell ukuthi iqondise kumaseli afanele. Ama-receptor e-CAR angezwe kuma-T cell angathola amamaki athile kumaseli omdlavuza. Lokhu kwenza kube nokwenzeka ukunikeza ukwelashwa okuhlosiwe. Le ndlela ehlosiwe ilimaza amaseli anempilo kancane ngangokunokwenzeka futhi yehlisa ubungozi bemiphumela engemihle eza nokwelashwa kwendabuko okufana nokwelapha ngamakhemikhali.
Kodwa kubalulekile ukukhumbula ukuthi ukwelashwa kwe-CAR T-cell kuseyindawo entsha esashintsha. Abacwaningi nodokotela basebenza kanzima ukuxazulula izinkinga ezifana nezindleko eziphezulu, amathuba okuba nemiphumela emibi kakhulu, kanye neqiniso lokuthi kusebenza kuphela ezinhlotsheni ezithile zomdlavuza.
Ekugcineni, ukwelashwa kwe-CAR T cell kwe-myeloma eminingi e-china kubonise ukuthi kuyindlela ephumelela kakhulu yokwelapha lo mdlavuza. Noma kuyindlela ethembisayo futhi enamandla, izifundo eziningi nezivivinyo zomtholampilo ziyadingeka ukuze kuthuthukiswe futhi kutholwe izindlela ezintsha zokuyisebenzisa. Ukwelashwa kwe-CAR T-cell kungashintsha indlela umdlavuza welashwa ngayo futhi kwenze izinto zibe ngcono kubantu emhlabeni wonke uma uqhubeka nokuba ngcono.
Umbandela Wokufaka Wokwelashwa Kwe-CAR T-Cell:
- Iziguli ezine-CD19+ B-cell Lymphoma (Okungenani inhlanganisela yangaphambili yemithi yokwelapha ngamakhemikhali emi-2)
- Ukuze ube neminyaka emi-3 kuye kwengama-75
- Isikolo se-ECOG ≤2
- Abesifazane abanamandla okuzala kumele babe nomchamo ukukhulelwaukuhlolwa kuthathwe futhi kwatholakala ukuthi awunayo ngaphambi kokwelashwa. Zonke iziguli ziyavuma ukusebenzisa izindlela ezinokwethenjelwa zokuvimbela inzalo phakathi nenkathi yesilingo futhi kuze kube yilapho kulandelwa okokugcina.
Imibandela Yokungafakwa Ye-CAR T-Cell Therapy:
- I-Intracranial hypertension noma ukuquleka
- Ukuhluleka kokuphefumula
- Kusatshalaliswe i-intravascular coagulation
- I-Hematosepsis noma ukutheleleka okusebenzayo okungalawulwa
- Okungalawulwa isifo sikashukela
Ukwelashwa Kwe-CAR T-Cell Kugunyazwe Yi-USFDA
UKYMRIAH
I-B-cell precursor acute lymphoblastic leukemia, ebuyele emuva noma i-refractory isakaza i-B-cell lymphoma enkulu
Izinga lokuphendula eliphelele (CR): >90%
Ithagethi: CD19
Price: $ 475,000
Isikhathi sokugunyaza: Agasti 30, 2017
YESCARTA
I-B-cell lymphoma enkulu ebuyele emuva noma ephikisayo, ebuyele emuva noma ephikisayo ye-follicular cell lymphoma.
Izinga lokuphendula eliphelele le-Non-Hodgkin's lymphoma (CR): 51%
Ithagethi: CD19
Price: $ 373,000
Isikhathi sokugunyazwa: 2017 Okthoba 18
TECARTUS
I-B-cell lymphoma ebuyiselwe emuva noma ephikisayo
I-Mantle cell lymphoma Izinga lokuphendula eliphelele (CR): 67%
Ithagethi: CD19
Price: $ 373,000
Isikhathi esivunyelwe: Okthoba 18, 2017
BREYANZI
I-B-cell lymphoma ebuyiselwe emuva noma ephikisayo
Izinga lokuphendula eliphelele (CR): 54%
Ithagethi: CD19
Price: $ 410,300
Isikhathi esivunyelwe: Okthoba 18, 2017
I-ABECMA
I-Myeloma Ephindaphindekayo noma Ephikisayo
Izinga lokuphendula eliphelele: 28%
Ithagethi: CD19
Price: $ 419,500
Kuvunyelwe: Okthoba 18, 2017
Yimiphi imiphumela emibi ye-CAR-T Cell Therapy?
Ngezansi eminye yemiphumela emibi yokwelashwa kwe-CAR T-Cell.
- I-Cytokine release syndrome (CRS): Umthelela oseceleni ovame kakhulu futhi okungenzeka ubaluleke kakhulu wokwelashwa kwe-CAR T-cell i-cytokine release syndrome (CRS). Izimpawu ezinjengomkhuhlane, okuhlanganisa imfiva, ukukhathala, ikhanda elibuhlungu, nobuhlungu bemisipha, zibangelwa ukukhiqizwa kwama-T cell ashintshiwe ama-cytokines. Ezimweni ezimbi kakhulu, i-CRS ingase ibangele izinga lokushisa eliphezulu, i-hypotension, ukwehluleka kwezitho, ngisho nemiphumela engase ibulale.
- Ubuthi Bezinzwa: Ezinye iziguli zingase zibe nemiphumela engemihle yemizwa, engase ihluke kakhulu kusukela kuzimpawu ezingathí sina njengokudideka okuncane kanye nokudideka kuye kwezibucayi kakhulu njengokuquleka, ukudangala, kanye ne-encephalopathy. Ngemuva kokujova i-CAR T-cell, ubuthi bezinzwa buvame ukwenzeka phakathi nesonto lokuqala.
- I-Cytopenias: Ukwelashwa kwe-CAR T-cell kungabangela ukubala kwamangqamuzana egazi aphansi, njenge-anemia (isibalo esiphansi samangqamuzana egazi abomvu), i-neutropenia (isibalo esiphansi samangqamuzana egazi amhlophe), kanye mthombosia (isibalo seplatelet esiphansi). Amagciwane, ukopha, nokukhathala kuphakathi kwezingozi ezingabhebhethekiswa yilezi cytopenias.
- Amagciwane: Ukucindezelwa kwe-CAR T-cell therapy kwamangqamuzana omzimba anempilo kwandisa ingozi yokutheleleka ngamagciwane, igciwane kanye nesikhunta. Ukuvimbela izifo, iziguli kungase kudingeke zibhekwe eduze futhi zinikezwe imithi yokuzivikela.
- I-Tumor Lysis Syndrome (TLS): Ngemva kokwelashwa kwe-CAR T-cell, kwezinye izimo kungenzeka ukuthi amanani amakhulu wokuqukethwe kwamangqamuzana akhishelwe emithanjeni yegazi ngenxa yokubulawa ngokushesha kwamaseli esimila. Lokhu kungase kubangele ukuphazamiseka kwezinqubo ze-metabolic, okufana namazinga e-potassium eningi, i-uric acid, ne-phosphate, okungase kulimaze izinso futhi kubangele nezinye izinkinga.
- I-Hypogammaglobulinemia: Ukwelashwa kwe-CAR T-cell kunamandla okunciphisa ukwakheka kwe-antibody, okungase kubangele i-hypogammaglobulinemia. Lokhu kungase kwenze izifo eziphindelelayo zibe nokwenzeka kakhulu futhi kubize ukuqhubeka kwemithi yokubuyisela amasosha omzimba.
- Ubuthi Bomzimba: I-CAR T-cell therapy inamandla okulimaza izitho eziningana, okuhlanganisa inhliziyo, amaphaphu, isibindi, nezinso. Lokhu kungase kuholele ekuhlolweni kokusebenza okungavamile kwezinso, izinkinga zokuphefumula, izinkinga zenhliziyo, nokuhlolwa kokusebenza okungavamile kwesibindi.
- I-Hemophagocytic lymphohistiocytosis (HLH): Isifo esingandile kodwa esibulalayo esibizwa ngokuthi i-hemophagocytic lymphohistiocytosis (HLH) singakhula ngenxa yokwelashwa kwe-CAR T-cell. Kuhilela ukusebenza ngokweqile kwamangqamuzana omzimba omzimba, okubangela ukulimala okukhulu kwezitho nokuvuvukala.
- I-Hypotension kanye nokugcinwa koketshezi: Njengomphumela wama-cytokines akhishwa amaseli e-CAR T, ezinye iziguli zingase zibe nomfutho wegazi ophansi (hypotension) nokugcinwa koketshezi. Ukubhekana nalezi zimpawu, kungase kudingeke izinyathelo ezisekelayo ezihlanganisa uketshezi olufakwa emthanjeni nezidakamizwa.
- Izifo Zesibili: Imibiko yezifo zesibili ezibulalayo ezivela ngemva kokwelashwa kwe-CAR T-cell ikhona, kungakhathaliseki ukuthi inqabile. Njengamanje ucwaningo luyenziwa mayelana namathuba ezifo zesibili kanye nezingozi zesikhathi eside.
Kubalulekile ukukhumbula ukuthi akusona sonke isiguli esizoba nale miphumela engemihle nokuthi izinga lomuntu ngamunye lokuzwela lizohluka. Ukuze kuncishiswe futhi kuncishiswe le miphumela emibi engaba khona, ithimba lezokwelapha lihlolisisa iziguli ngaphambi, phakathi, nangemuva kokwelashwa kwe-CAR T-cell.
Ubude besikhathi
Bheka ngezansi kwengqikithi yesikhathi esidingekayo ukuze kuqedelwe inqubo yokwelapha ye-CAR T-Cell. Kodwa-ke, isikhathi esinqunyiwe sincike kakhulu ebangeni lelebhu esuka esibhedlela elungise ama-CAR.
- Ukuhlolwa nokuhlolwa: isonto elilodwa
- Ukwelashwa kwangaphambili & Ukuqoqwa kwe-T-Cell: isonto elilodwa
- Ukulungiswa kwe-T-Cell nokubuya: amasonto amabili kuya kwamathathu
- Ukuhlaziywa kwe-1st Ukusebenza kahle: amaviki amathathu
- Ukuhlaziywa kwe-2nd Ukusebenza kahle: amaviki amathathu.
Isikhathi esiphelele: 10-12 Amaviki
ICancerFax Ingakusiza Kanjani Ukuthola I-CAR T Cell Therapy?
Uma kuziwa ekukhetheni umlingani ofanele wohambo lwakho lokwelashwa komdlavuza, iCancerFax igqama njengokukhanya kokwesekwa nobungcweti. Ngokuhlangenwe nakho okuningi ekunikezeni ukwelashwa kwe-CAR T-cell, siyakubona ukubaluleka kwempilo yakho kanye nesidingo sokuthola ukunakekelwa okuhle kakhulu. Okwenza iCancerFax ihluke yiqembu lethu lochwepheshe bezempilo abazinikele nabanozwelo ababeka ukuphila kwakho kahle kuqala phakathi nenqubo yokwelashwa.
Sikholelwa ekwelashweni komuntu siqu ngoba siyaqaphela ukuthi isiguli ngasinye sihlukile futhi sidinga ukunakekelwa komuntu ngamunye. Ukuzinikela kwethu ekwenzeni okuhle kubonakala ekukhetheni okuphelele kochwepheshe abanolwazi olunzulu nokusebenzisana nezibhedlela eziningi, siqinisekisa ukuthi uthola izinketho ezilungele kangcono izidingo zakho ngaphandle kokudela ikhwalithi. Kule minyaka eyishumi edlule, iCancerFax ibe yinkomba eyethenjwayo yeziguli ezivela emazweni angaphezu kwangu-8, futhi sizinikele ekwandiseni izinga elifanayo lokunakekela nokusekelwa kini. Xhumana nathi namuhla ukuze uthole i- I-CAR T Cell therapy engcono kakhulu e-China.
ICancerFax ibambisene ne izibhedlela eziphezulu zomdlavuza kanye ne-hematology eChina okuyizikhungo ezigunyaziwe zokuphathwa kokwelashwa kwamaseli e-CAR T. Ngokusekelwe esimweni sesiguli sezempilo nezezimali kanye nokuba seduze nalapho siya khona, siphakamisa isibhedlela esifaneleka kakhulu.
imibuzo ejwayelekile ukubuzwa
Yiziphi izinhlobo zomdlavuza ezifanelekela ukwelashwa kwe-CAR T-Cell eChina?
E-China, ukwelashwa kwe-CAR T-cell kuvunyelwe ngokuyinhloko futhi kusetshenziselwe ukwelapha izifo ze-hematological, njenge-lymphoma, i-leukemia, ne-myeloma.
Yize kukhona ezinye izivivinyo zemitholampilo nemizamo yocwaningo ehlola ukwelashwa kwe-CAR T-cell yamathumba aqinile, inqubekelaphambili kule ndawo ihambe kancane uma iqhathaniswa ne-hematological malignancies.
Ngokolwazi olutholakalayo, izindlela zokwelapha ze-CAR T-cell zamathumba aqinile zenza u-9% kuphela wengqikithi yokwelashwa kwe-CAR T-cell eyenziwa eChina.
Kusebenza kanjani ukusebenza kwe-CAR T Cell therapy e-China uma kuqhathaniswa nezinye izindlela zokwelapha?
Ukusebenza kokwelashwa kwe-chimeric antigen receptor T-cell (CAR-T) e-China kuqhathaniswe nezinye izindlela zokwelapha ngokuhlolwa okubanzi kwemitholampilo nocwaningo. Kusukela ngo-2022, i-China inenani elikhulu lezifundo zomtholampilo ze-CAR-T kune-United States, ikakhulukazi ezifweni ze-hematological. Izindlela zokwelapha ezimbili ze-CAR-T, i-axicabtagene ciloleucel (Yescarta) kanye ne-relmacabtagene autoleucel (Carteyva), zigunyazwe e-China yi-National Medical Products Administration (NMPA).
Ukwelashwa kwe-CAR-T e-China kubonise ukusebenza ngempumelelo ezinkingeni ezihlukahlukene ze-hematological, okuhlanganisa i-B-cell acute lymphoblastic leukemia (ALL), i-lymphoma, ne-multiple myeloma (MM). Nokho, izinselele zisekhona, njengezindleko eziphezulu, inqubo yokukhiqiza edla isikhathi, kanye nezenzakalo ezimbi ezihlobene nokuzivikela komzimba. Ukuze kubhekwane nalezi zinkinga, abacwaningi baseShayina bakha amasu okuthuthukisa ukwelashwa kwe-CAR-T, okuhlanganisa ukuthuthukiswa kwemikhiqizo ye-allogeneic CAR-T kanye nokusetshenziswa kwezinye izizinda ze-costimulatory.
Kafushane, ukwelashwa kwe-CAR-T e-China kubonise imiphumela ethembisayo ku-hematological malignancies, ngenani elikhulu lezivivinyo zomtholampilo uma kuqhathaniswa ne-United States. Kodwa-ke, izinselelo zisekhona, futhi ucwaningo olwengeziwe luyadingeka ukuze kwandiswe ukwelashwa futhi andise ukusetshenziswa kwakho kube izimila eziqinile.
Yimiphi imiphumela emibi eye yabonwa ngokwelashwa kwe-CAR T Cell e-China?
E-China, imiphumela emibi ebonwe ekwelashweni kwe-CAR T-cell ihlanganisa:
- I-Cytokine release syndrome (CRS)
- Neurotoxicity noma izehlakalo zezinzwa
– Amagciwane, ikakhulukazi izifo ezibangelwa amagciwane
-B cell depletion (i-aplasia)
- Hypogammaglobulinemia
- Cytopenia
Le miphumela engemihle ayiyona e-China kuphela kodwa ivamile kuwo wonke ukwelashwa kwe-CAR T-cell emhlabeni wonke. Ukuphathwa nokuvimbela le miphumela engemihle kubalulekile ekuqinisekiseni ukuphepha kwesiguli kanye nokwenza ngcono imiphumela yokwelashwa.
Kubiza kangakanani ukwelashwa kwe-CAR T e-China?
Ukuthengwa kwezitolo okudayisa yonke impahla kwe-CAR-T cell therapy e-China kuvamise ukuzungeze i-Chinese Yuan (CNY) 1,200,000, elingana no-US$170,000. Ukuphumelela kwezindleko zokwelashwa kwamaseli e-CAR-T e-China kuyahlukahluka kuye ngokwelashwa okuqondile kanye nesimo sesiguli. Isibonelo, isilinganiso esikhulayo sokusebenza ngempumelelo kwezindleko (ICER) se-Axicabtagene ciloleucel (Axi-cel) ngokumelene nezinga lokunakekelwa (SOC) ezigulini ezine-B-cell lymphoma (DLBCL) esabalele enkulu kumugqa wesibili (2L) cishe I-CNY 363,977 ngonyaka wokuphila olungiswe ngekhwalithi (QALY). Kodwa-ke, lezi zindlela zokwelapha azibhekwa njengezingabizi kakhulu kunoma yiziphi izilungiselelo ze-DLBCL ezigulini ze-DLBCL emngceleni onconywe yi-World Health Organization (WHO) wokuvuma ukukhokha. Ukwehliswa kwentengo yokwelashwa kwe-CAR-T kuyindlela eyinhloko yokwehlisa ama-ICER nokuqinisekisa ukuthi izindleko zomuthi zilingana nezinzuzo zezempilo zesiguli.
Ingabe zikhona izivivinyo zomtholampilo eziqhubekayo zokwelashwa kwe-CAR-T e-China?
Yebo, kukhona izivivinyo zomtholampilo eziqhubekayo zokwelashwa kwamaseli e-CAR-T e-China. Kusukela ngoJanuwari 2024 kunezilingo zomtholampilo eziqhubekayo ezingaphezu kuka-700 zokwelashwa kwe-CAR T Cell e-China. I-China ibe yizwe elinezinhlolo ze-CAR-T ezibhaliswe kakhulu, futhi lo mkhuba uye waqhubeka kusukela lapho. Uhulumeni waseShayina utshale imali eningi ocwaningweni lwe-CAR-T, futhi izwe linenani elikhulu lezivivinyo zemitholampilo kanye nocwaningo oluyisisekelo kulo mkhakha. Lezi zinhlolo zinweba ububanzi bokwelashwa ukusuka emazingeni e-hematological kuye kumathumba esloid kanye nokunye ukuphazamiseka futhi.
Ngisithola kanjani isibhedlela noma udokotela ongcono kakhulu ohlinzeka ngokwelashwa kwe-CAR T-cell e-China?
ICancerFax iyakuqonda ukubaluleka kokukhetha indawo engcono kakhulu kanye nochwepheshe be-CAR T cell therapy eChina. Inkonzo yethu esizinikele igxile ekuxhumaniseni abantu nokunakekelwa komdlavuza okungcono kakhulu ngezindleko ezithengekayo. Sisebenza ikakhulukazi nezibhedlela ezisezingeni eliphezulu ze-hematology nezomdlavuza e-China ezithole imvume yokuphatha ukwelashwa kwamaseli e-CAR T. Sisiza iziguli ukuthi zikhethe inketho engcono ngokwezidingo nezimfuneko zazo.
Yiziphi izidingo zokuthi ufanelekile ukuthola ukwelashwa kwe-CAR T- CELL e-China?
Izidingo zokufaneleka zokwelashwa kwe-CAR T cell therapy e-China ziyahlukahluka kuye ngokwelashwa okuqondile kanye nesimo sesiguli. Ngokuvamile, iziguli ezine-hematological malignancies, njenge-lymphoma, i-leukemia, ne-myeloma, yizo ezikhethwa kakhulu ekwelapheni kwe-CAR T cell eChina.
Iziguli kufanele zibe nokuxilongwa okuqinisekisiwe kohlobo oluthile lomdlavuza futhi zehlulekile ukuphendula ekwelashweni okujwayelekile, okufana nokwelashwa ngamakhemikhali noma ukwelapha ngemisebe.
Ukwengeza, iziguli kufanele zihlangabezane nemibandela ethile yezempilo, njengokuba nokusebenza kwezitho okwanele nokungabi nezifo ezisebenzayo noma ezinye izimo zezokwelapha ezingathi sína ezingase ziphazamise ukwelashwa. Imibandela yokufaneleka yokuhlolwa ngakunye komtholampilo ingase yehluke, futhi iziguli kufanele zihlangabezane nezimfuneko ezithile zocwaningo ukuze zibambe iqhaza.
Ukuze kubhekwe njengokufanelekile ukuthola ukwelashwa kwe-CAR T cell e-China, iziguli kufanele zihlangabezane nemibandela ethile. Lezi zindlela zokunquma zihlanganisa i-CD19+ B-cell Lymphoma enezikhathi okungenani ezimbili ezihlanganisiwe zokwelashwa ngamakhemikhali, ibanga lobudala leminyaka emi-3 kuye kwengama-75, kanye nesikolo se-ECOG esingu-≤2. Ngaphezu kwalokho, ezigulini zesifazane ezinekhono lokuzala, ukuhlolwa kokukhulelwa komchamo kufanele kwenziwe futhi kuqinisekiswe ukuthi awunalo ngaphambi kokuba ukwelashwa kuqale. Ngaphezu kwalokho, zonke iziguli kufanele zivume ukusebenzisa indlela ethembekile yokuvimbela inzalo phakathi nokuhlolwa futhi kuze kube sekulandeleni kokugcina.
Ingabe ikhona imithetho noma imikhawulo yeziguli zakwamanye amazwe ezivakashela eChina ukuze zithole ukwelashwa nge-CAR T cell therapy?
Ayikho imingcele enjalo ezigulini zakwamanye amazwe. Kodwa-ke, ukuthola ukwelashwa okungcono kakhulu e-China kudinga ukugunyazwa yiziphathimandla zezokwelapha kanye ne-visa yezokwelapha.
Singalindela ngokushesha kangakanani ukubona imiphumela yokwelashwa kwe-Car T-Cell E-China?
Isikhathi sokuthi iziguli zibone imiphumela yokwelashwa kwe-CAR T cell e-China singahluka. Ngokuvamile, izikena zenziwa ngemva kwamasonto angu-2-3 ukuze kubhekwe umphumela wokwelashwa kwe-CAR T cell. Ukwelashwa kwamaseli e-CAR T kuzuze impumelelo enkulu ekwelapheni izifo ze-hematological, futhi i-China isibe izwe elihamba phambili ezivivinyweni zokwelashwa ze-CAR T. Kodwa-ke, kubalulekile ukuqaphela ukuthi imiphumela yokwelashwa kwe-CAR T cell ingahluka esigulini ngasinye, futhi umugqa wesikhathi othize wokubona imiphumela ungancika ezintweni ezifana nesimo sesiguli, uhlobo lomdlavuza olashwayo, kanye ne-CAR T ethize. kusetshenziswa i-cell therapy. Nakuba ukwelapha kuye kwabonisa imiphumela ephawulekayo yomtholampilo, kuhlanganise namazinga aphezulu okuphendula, isikhathi esiqondile lapho isiguli singalindela ukubona imiphumela singase singachazwa emhlabeni wonke futhi singahluka kumuntu ngamunye. Ngakho-ke, kunconywa ukuthi iziguli zithintane nabahlinzeki bazo bezempilo kanye nabaphenyi besilingo somtholampilo ukuze bathole ulwazi oluthile mayelana nomugqa wesikhathi olindelekile wokubona imiphumela evela ekwelashweni kweseli ye-CAR T.
Ingabe ukwelashwa kokulandelela isikhathi eside noma ukuqapha kuyadingeka ezigulini ezithole ukwelashwa kwe-CAR T-Cell e-China?
Yebo, ukwelashwa kokulandelela isikhathi eside noma ukuqapha kuyadingeka ezigulini eziye zelashwa nge-CAR T cell e-China. I-CAR T cell therapy ibonise imiphumela emangalisayo yomtholampilo ekwelapheni izifo ze-hematological, kodwa ingaba nemiphumela engemihle engaba khona, njenge-cytokine release syndrome (CRS) kanye neurotoxicity.
Ngakho-ke, iziguli eziye zathola ukwelashwa kwe-CAR T cell zidinga ukuqapha okuseduze kwemiphumela emibi engase ibe khona kanye nokulandelela isikhathi eside ukuze kuhlolwe ukuqina kwempendulo kanye nokubuyela emuva komdlavuza. Ubude besikhathi sokulandelela bungahluka kuye ngokwelashwa okuqondile kanye nesimo sesiguli, kodwa ngokuvamile kuhilela ukuhlolwa okuvamile nokuhlolwa kwezithombe ukuze kuqashwe impilo yesiguli futhi kutholwe noma yikuphi ukuphindeka okungenzeka komdlavuza.
Ukwengeza, iziguli zingase zidinge ukunakekelwa okusekelayo, njengemithi yokuphatha imiphumela engemihle noma ukwelashwa okwengeziwe uma umdlavuza uphinda uvela.
Kungenzeka yini ukuhlanganisa ukwelashwa kwe-CAR T cell nezinye izindlela zokwelapha ezifana ne-chemotherapy, imisebe, noma ukufakelwa komnkantsha?
Yebo, kungenzeka ukuhlanganisa i-CAR T cell therapy nezinye izindlela zokwelapha ezinjengokwelashwa ngamakhemikhali, imisebe, noma ukufakelwa komnkantsha. Kukhona intshisekelo ekhulayo yokuhlanganisa ukwelashwa kweseli ye-CAR T namanye ama-anticancer ukuze kuthuthukiswe imiphumela yokwelashwa, ikakhulukazi kumongo we-hematological malignancies. Isibonelo, ku-myeloma, izinhlanganisela zingabandakanya ukwelashwa kwe-myeloma okujwayelekile okunikezwa ngemva kokumnika kwe-CAR T-cell njengesu lokunakekela.
Ukwengeza, inhlanganisela ye-radiotherapy ne-CAR-T cell therapy ibonise imiphumela ethembisayo ekwandiseni ukuvikeleka okuthile nasekudaleni indawo ekahle yesimila microenvironment yamaseli e-CAR-T kumathumba aqinile.
Ngaphezu kwalokho, inhlanganisela yokwelapha ngamakhemikhali ne-CAR-T cell therapy iye yahlolwa njengesu lokunqoba izithiyo ekwelapheni kwamaseli e-CAR-T futhi inikeze imiphumela ehambisanayo, ikakhulukazi ekwelapheni izimila eziqinile. Lezi zindlela zokuhlanganisa zihlose ukuthuthukisa ukuphepha nokusebenza ngempumelelo kwe-CAR-T cell therapy ngokushintsha i-tumor microenvironment, ukwenza kahle ukwakheka kwe-CAR, futhi ngokunokwenzeka kuqondiswe kuma-antigen amaningi.
Iyiphi inqubekelaphambili noma intuthuko eyenzekayo ocwaningweni lwe-CAR T-cell therapy ngaphakathi kwe-China?
E-China, ucwaningo lwe-CAR T cell therapy luthuthuka ngokushesha, njengoba izwe linesivivinyo esiningi kakhulu se-CAR T cell kusukela ngo-2017. Uhulumeni waseShayina utshale imali eningi ekwelapheni kwamaseli e-CAR T, futhi izwe linenani elikhulu lezivivinyo zomtholampilo kanye neziyisisekelo. ucwaningo kulo mkhakha. Izindlela zokwelapha ze-CAR T cell zivunyelwe ukwelapha izifo ze-hematological, ezifana ne-diffuse big-cell lymphoma (DLBCL).
Abacwaningi baseShayina bahlola amasu ahlukahlukene okuthuthukisa ukwelashwa kwamaseli e-CAR T, okuhlanganisa ukuthuthukiswa kwezakhi ezintsha ze-CAR, izindlela zokwelapha ezihlangene nezinye izindlela zokwelapha, kanye nokusetshenziswa kwamaseli e-CAR T kumathumba aqinile. Kodwa-ke, izinselele zisekhona, njengobunzima bokukhiqiza nokuphatha, izindleko eziphezulu zokwelashwa, kanye nesidingo sokuhlolwa okunengqondo nokwangempela kwemitholampilo.
Ngaphandle kokuphazamiseka kwezivivinyo zomtholampilo ngenxa yobhubhane lwe-COVID-19, ucwaningo lusaqhubeka e-China, lapho inhlangano elawulayo yezwe, i-National Medical Products Administration (NMPA), igunyaze izindlela zokwelapha ezimbili kuphela ze-CAR T njengemininingwane yakamuva etholakalayo.
Yiziphi izinyathelo ezijwayelekile ezihilelekile ekuvakasheleni e-China ukuze uthole ukwelashwa kwe-CAR-T-cell?
Izinyathelo ezijwayelekile ezihilelekile ekuhambeleni e-China ukuze uthole ukwelashwa kwe-CAR T cell zingahluka kuye ngesibhedlela esithile noma isikhungo sokwelashwa. Nokho, ezinye izinyathelo ezivamile zingafaka:
1. Ukucwaninga izibhedlela noma izikhungo zokwelapha eShayina ezihlinzeka nge-CAR T cell therapy futhi nokukhetha eyodwa ehlangabezana nezidingo zakho.
2. Ukuxhumana nesibhedlela noma isikhungo sokwelashwa ukuze ubuze ngenqubo yokwelashwa, okuhlanganisa izindleko, izimfuneko zokufaneleka, nanoma imaphi amadokhumenti adingekayo.
3. Ukuthola ukudluliselwa kumhlinzeki wakho wokunakekelwa kwezempilo kanye nokuhlinzeka ngamarekhodi ezokwelapha esibhedlela noma esikhungweni sokwelashwa.
4. Ukufaka isicelo se-visa yezokwelapha ukuze uye e-China ukuze uyokwelashwa.
5. Ukuzilungisela uhambo nendawo yokuhlala kanye nanoma yimaphi amalungu omndeni ahambisana nawo.
6. Ukuhlolwa nokuhlolwa kwezokwelapha lapho ufika esibhedlela noma esikhungweni sokwelashwa.
7. Ukuthola ukwelashwa kwe-CAR T cell kanye nokunakekelwa okudingekayo kokulandelela.
8. Ukubuyela ekhaya nokuqhubeka nokunakekelwa nokuqapha isikhathi eside.
Kubalulekile ukuqaphela ukuthi izinyathelo eziqondile ezihilelekile ekuhambeleni e-China ukuze uthole ukwelashwa kwe-CAR T cell zingahluka kuye ngokuthi isibhedlela noma isikhungo sokwelashwa kanye nezimo zesiguli ngasinye. Kutuswa ukuthi iziguli zithintane nabahlinzeki bazo bezempilo kanye nesibhedlela noma isikhungo sokwelashwa ukuze uthole ulwazi oluqondile mayelana nenqubo yokwelashwa nezidingo zokuhamba.
ICancerFax ikunakekela zonke lezi zinyathelo ukuze uhlale ugxile ekwelashweni kuyilapho thina sinakekela zonke ezinye izinto.
Lithini izinga lempumelelo ye-CAR T e-China?
I-CAR T-cell therapy ikhombise imiphumela ethembisayo ekwelapheni umdlavuza wegazi eChina. Kusukela ngoJanuwari 2024, iChina yaba nezivivinyo zemitholampilo eziqhubekayo emhlabeni zokuhlola i-CAR T-cell therapy, ezingama-337 ezigxile kumdlavuza wegazi kwathi eziyi-111 zigxile kumathumba aqinile. Ukwelashwa kwe-CAR T-cell kwehlise izimila ku-75.9% weziguli ze-lymphoma isifo sazo sase sibuyile ngemuva kokwehluleka kokwelashwa kwangaphambilini. Iziguli ezingaphezu kwesigamu (51.7%) zazingenazo izimila ezitholakalayo ngemva kokwelashwa. Ngonyaka owodwa kamuva, i-76.8% yeziguli ze-lymphoma zahlala ziphila. I-China igunyaze izindlela zokwelapha ezimbili ze-CAR T-cell ezibizwa nge-FKC876 ne-Carteyva zokwelashwa komdlavuza. I-China ihamba phambili ocwaningweni nasekuthuthukisweni komhlaba wonke kwe-CAR T-cell therapy.