Ukwelashwa kwe-CAR T-Cell eKorea
Ingabe ufuna ukubhalisela ukwelashwa kwe-CAR T-Cell e-Korea?
Xhumana nathi ukuze uqedele izinsizakalo ze-concierge.
INingizimu Korea inaka kakhulu i-CAR T-cell therapy, okuwuhlobo olusha lwe-immunotherapy oseluthuthuke kakhulu. Kuhilela ukushintsha izakhi zofuzo zamaseli T esiguli ukuze akwazi ukwenza ama-chimeric antigen receptors (ama-CAR), angathola amaseli omdlavuza futhi awabulale. INingizimu Korea yenze ucwaningo oluningi kanye nentuthuko ekwelapheni kwamaseli e-CAR T, ngezivivinyo eziningi zemitholampilo nezikhungo zokwelapha ezinikelwe kule ndlela entsha. Ukwelashwa kwe-CAR T cell kube yimpumelelo eNingizimu Korea ngenxa yohlelo lwezwe lokunakekelwa kwezempilo nolwazi lwezobuchwepheshe. Lokhu kunikeze iziguli ezinomdlavuza wegazi ithemba futhi kwavula indlela yokwelashwa komdlavuza komuntu siqu esifundeni.
Ukwelashwa kwe-CAR T-Cell e-Korea - Intuthuko yakamuva
Juni 2023: I-CAR T-cell therapy isiphenduke indlela entsha yokwelapha umdlavuza. Kuyishintshile indlela esilwa ngayo nezinhlobo ezahlukene zomdlavuza. Eminyakeni yamuva nje, iSouth Korea yenze inqubekelaphambili enkulu kule ndawo, okubonisa ukuthi izinikele kangakanani ekufundeni nemibono emisha. Lesi siqeshana sizokhuluma ngezinye zentuthuko entsha ku I-CAR T-cell therapy eKorea. Izogxila kakhulu ezinguqukweni eziqavile ezibeke iSouth Korea esicongweni kulo mkhakha.
Izivivinyo Zemitholampilo Nokugunyazwa Kokulawula: INingizimu Korea iphishekele ngenkuthalo izivivinyo zomtholampilo zokwelashwa kwe-CAR T cell, okwenza isimo esikhuthaza ukuqamba okusha nokunakekela okugxile esigulini. Izwe belihamba phambili ekuhloleni izindlela zokwelapha izifo ze-hematological kanye nezimila eziqinile, phakathi kwezinye izinhlobo zomdlavuza. Ngokuphawulekayo, izivivinyo zomtholampilo zibonise imiphumela emihle, okuholele ekutheni i-CAR T cell therapy igunyazwe uhulumeni ukuze isetshenziswe okuthile.
Ukuthuthukiswa Kwezakhiwo Ezintsha Ze-CAR: Abacwaningi nososayensi eSouth Korea bebesebenza kanzima ukwenza ukwakhiwa okusha kwe-CAR okwenza ukwelashwa kwamaseli e-CAR T kusebenze kakhulu futhi kuphephe. Lokhu kuhlanganisa ukwenza intuthuko endleleni ama-chimeric antigen receptors enziwa ngayo ukuze amaseli e-CAR T akwazi ukuthola kangcono, enze kusebenze, futhi ahlale kumathumba. Lezi zinguquko ziholele emiphumeleni engcono yokwelashwa kanye nemiphumela engemihle embalwa.
Imithi Yokwelapha Ehlanganisiwe: Abacwaningi baseNingizimu Korea baphinde babheka ukuthi kungenzeka yini ukuxuba ukwelashwa kwamaseli e-CAR T nezinye izinhlobo zokwelapha, njengama-immune checkpoint inhibitors kanye nemithi yokwelapha eqondiwe. Abacwaningi bafuna ukuthuthukisa amazinga okuphendula futhi bazungeze izinkinga ezibangelwa izinhlobo ezahlukene zamathumba nendlela ezifihla ngayo kumasosha omzimba.
Ukukhiqiza Nokuthengisa: INingizimu Korea yenze inqubekelaphambili enkulu ekudaleni izinqubo zokwenza ukwelashwa kwe-CAR T cell okuqinile futhi okungakhuliswa. Lokhu kwenze ukuthi lezi zindlela zokwelapha zifakwe emakethe futhi zisetshenziswe abantu abaningi, okwenza kube lula kubantu abazidingayo ukuthi bakuthole.
INingizimu Korea manje isihamba phambili emhlabeni wonke kwezokwelapha nge-CAR T cell. Lokhu ikwenze ngokusebenzisa amakhono ayo okucwaninga, ulwazi lomtholampilo, kanye nohlaka lokulawula ukwenza inqubekelaphambili emangalisayo kule ndawo. Ukuzinikela kwezwe ekusunguleni izinto ezintsha kanye nesimo salo sokuhlanganyela socwaningo kuholele ekwakhiweni kwezakhiwo ezintsha ze-CAR, izivivinyo zokwelashwa eziyimpumelelo, kanye nokudayiswa kwalezi zindlela zokwelapha. Lokhu kuthuthukiswa okusha kunamandla amaningi okushintsha indlela umdlavuza welashwa ngayo futhi kuthuthukise imiphumela yesiguli, hhayi eSouth Korea kuphela kodwa emhlabeni wonke. INingizimu Korea kungenzeka ibe nomthelela omkhulu ekusaseni lokwelashwa kwe-CAR T cell njengoba umkhakha uqhubeka nokushintsha.
I-CAR T-cell therapy, eyakhiwe ngu-Novartis futhi idayiswa ngaphansi kwegama lomkhiqizo i-Kymriah, okwamanje ihlinzekwa yi-CAR T-cell Therapy Centre ezigulini ezingaphansi kweminyaka engama-25 eziphethwe i-B-cell acute lymphoblastic leukemia noma ezisakaza i-B- enkulu i-cell lymphoma. Ukwengeza, iziguli ezine-refractory diffuse B-cell lymphoma enkulu zigxile ekuhlolweni komtholampilo okwenziwa i-CRCO1, eyathuthukiswa inkampani ezinze e-Korea ebizwa ngokuthi i-Curocell. Ukwengeza, ngenxa yokuthi i-Korea yaziwa kabanzi njengehabhu le-CAR T-cell Therapy emhlabeni, izivivinyo zomtholampilo zokwelashwa kwe-CAR T-cell okwakhiwa ngu-Janssen nazo okwamanje zenziwa ezigulini ezibuye zabuyela emuva noma i-multiple myeloma esabelayo.
Ngaphambi kokuqala ukwelashwa, iziguli ezelashwa nge-CAR T-cell zidingeka ukuthi zixhumanise imizamo yazo neminyango eminingi yesibhedlela eyahlukene. Ukucacisa kabanzi, inani elikhulu lochwepheshe emikhakheni ehlobene eduze nesifo esithathelwanayo, i-neurology, i-cardiology, nokunakekelwa okujulile kuhileleke ekulawuleni okuphelele okwenzeka ngemva kokwelashwa.
Isikhungo se-CAR T-cell therapy njengamanje sibamba iqhaza “Kuphrojekthi Yesibhedlela Esigxile Ocwaningweni Nezocwaningo” nguMnyango Wezempilo Nenhlalakahle, futhi kulindeleke ukuthi sibe isikhungo sokwelapha amangqamuzana esihola ukwelashwa kwamaseli okusezingeni eliphezulu kanye nokwelashwa okuqondene nesiguli. kuziguli ze-hematological oncology. Lolu hlelo lwaqalwa nguMnyango Wezempilo Nezenhlalakahle.
Yiziphi izinkampani ezibambe iqhaza ekukhiqizeni ama-CAR T-Cells eNingizimu-Korea?
NgoNovemba 16, 2022, I-ViroMed, inkampani yaseKorea, yamemezela uhlelo lokwakha umuthi oyi-CAR-T. Ubuchwepheshe bokuthuthukisa izakhi zofuzo ze-CAR, ubuchwepheshe bokukhiqiza i-vector, kanye nobuchwepheshe be-ex vivo bokudluliselwa kofuzo nokwanda kwamaseli konke kuyatholakala ebhizinisini ukuze kuthuthukiswe izidakamizwa ze-CAR-T. Ngemva kokuthengisa i-“VM801,” ubuchwepheshe be-CAR-T be-ViroMed, ku-US Bluebird Bio ngamabhiliyoni angu-56.8 awinwe ngoDisemba 2015, inkampani ihlela ukukhiqiza imikhiqizo emithathu ye-CAR-T.
Ngaphezu kwalokho, i-AbClon ithuthukisa ukwelashwa komdlavuza wegazi okusekelwe kubuchwepheshe obuthuthukiswe ithimba labacwaningi eliholwa uprofesa Jung Jun-ho waseSeoul National University ngoFebhuwari, okuphephile kunezidakamizwa zamanje ze-CAR-T. Ubuchwepheshe beqembu baziwa ngokuzihlukanisa nemithi yamanje ngokunciphisa kakhulu i-cytokine release syndrome (CRS), umphumela ongaseceleni oyingozi wezidakamizwa ze-CAR-T ezingabangela umfutho wegazi ophakeme, imfiva, ngisho nokufa ezigulini.
Ngaphezu kwalokho, iGreen Cross Cell, inkampani engaphansi kweGreen Cross, ihlola futhi iqinisekisa abantu abazongenela izidakamizwa ze-CAR-T ukuze bathole ukwelashwa komdlavuza oqinile. Inkampani ihlose ukwenza ucwaningo ukuze iqale ukuhlolwa kwangaphambi komtholampilo ngonyaka ozayo. Selokhu iqoke u-Son Ji-woong njengenhloko ye-Life Science Business Division ngoFebhuwari, i-LG Chem kuthiwa ibicabanga ukusebenzisa ubuchwepheshe obuhlobene nezidakamizwa ze-CAR-T, ukukhiqizwa kwezidakamizwa zesifo sikashukela kanye nemithi yokulwa nomdlavuza okuyiyo. umgomo oyinhloko we-R&D wenkampani.
I-Curocell, isiqalo se-biotech saseNingizimu Korea esaphayona ukwelapha ngamaseli e-CAR-T, sihlela ukwethula uvivinyo lomtholampilo lwenoveli yokwelapha ngamaseli e-CAR-T eqondise kokubili umdlavuza wegazi kanye nezimila eziqinile.
UCurocell usanda kuhambisa isicelo se-IND sokuvivinywa komtholampilo kwe-CAR-T cell therapy eKorea, kanti isikhulu esiphezulu sale nkampani uKim Gun-soo utshele iMaeil Business Newspaper ukuthi uMnyango Wezokudla Nezidakamizwa kulindeleke ukuthi ukugunyaze kule nyanga.
UCurocell usevele wenze umfelandawonye wamasu nabakwaSamsung Medical Center ukuze baqale ukuqulwa kwaleli cala ngokushesha uma seligunyaziwe, ngokusho kukaKim, onethemba lokuthi uzothola ukwelashwa komdlavuza ezigulini zaseKorea ngokushesha okukhulu.
I-CAR-T iyi-immunotherapy ehlelelwe ukuhlonza nokubhubhisa amangqamuzana omdlavuza. Amaseli e-T asuka esigulini esisodwa akhiwe ngofuzo elebhu ukuze akhiqize ama-antigen receptors aqondene nomdlavuza ukuze adale lokhu kwelashwa. Ngemva kwalokho, amangqamuzana alwa nomdlavuza aphinde afakwe emzimbeni wesiguli.
Ukwelashwa ngamaseli e-CAR-T kuboniswe ukuthi kuphumelele kakhulu kunanoma ikuphi okunye ukwelashwa komdlavuza okutholakalayo njengamanje. Ngokusho kukaKim, naphezu kokuhluleka kwezinye izindlela zokwelapha, amaphesenti angu-82 eziguli ze-acute leukemia kanye namaphesenti angu-32-36 eziguli ze-lymphoma angenawo umdlavuza ngokufakwa kwe-CAR-T cell eyodwa.
Kodwa-ke, imiphumela esebenza kahle kakhulu ye-CART ikhawulelwe ekwelapheni amangqamuzana omdlavuza wegazi futhi ayikwazi ukuphindaphindeka kumathumba aqinile ngenxa ye-immune checkpoint receptor (PD-1) etholakala kumaseli omzimba eziguli ezinomdlavuza oqinile, ovimbela ukusebenza kwamaseli omzimba.
I-immune checkpoint receptor isebenza njengebhuleki emandleni okusebenza kwamaseli omzimba. Lapho ama-immune checkpoint receptors afana ne-PD-1 egcizelelwe ngokweqile, amandla amaseli omzimba okukhipha amaseli omdlavuza ayancipha, okwenza ukususwa kwesimila kube nzima kakhulu.
Ubuchwepheshe be-Curocell's OVIS (Overcome Immune Suppression) bunqoba lo mkhawulo, buvumela ukwelapha kwamaseli e-CAR-T ukuthi kusetshenziselwe ukwelapha izimila eziqinile. I-OVIS ubuchwepheshe bobunjiniyela bezakhi zofuzo obusebenzisa ukuguqulwa kwezakhi zofuzo zamaseli omzimba ukucindezela i-immune checkpoint receptor RNA (ribonucleic acid). Ukwelashwa okusha kweseli ye-CAR-T okwenziwe ngalobu buchwepheshe kube yimpumelelo kakhulu kunokwelashwa kwamanje kwe-CAR-T kumodeli yezilwane, ngokusho kukaKim.
Ngaphandle kokwelashwa kwe-Curocell, azikho izindlela zokwelapha zamaseli e-CAR-T ezitholakalayo njengamanje noma ezivivinyweni zomtholampilo ezizoqondisa kokubili umdlavuza wegazi namathumba aqinile, ngokusho kukaCurocell.
Ungasifaka kanjani isicelo sokwelashwa kwe-CAR T-Cell eKorea?
Thumela imibiko yakho yezempilo ku info@cancerfax.com noma WhatsApp kubo +1-213 789-56-55. Thumela imibiko elandelayo ukuze uthole umbono kanye nesilinganiso:
1) Isifinyezo sezokwelapha
2) Imibiko yegazi yakamuva
3) I-Biopsy
4) I-PET Scan yakamuva
5) I-biopsy yomnkantsha (Uma ikhona)
6) Noma yimiphi eminye imibiko efanele kanye nokuskena
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. Ukuhlaziywa kombiko kulandelwa ukubonisana ngevidiyo okuku-inthanethi nochwepheshe. Siphinde sithole isilinganiso esivela esibhedlela ngokwelashwa okuphelele. Lokhu kukusiza ekuhleleleni sonke isikhathi sokwelashwa.
Uma usunqume ukuvakashela ukwelashwa, sihlela incwadi ye-visa yezokwelapha kanye neminye imibhalo edingekayo evela esibhedlela. Siphinde sikusize futhi sikuqondise ekufakeni isicelo se-visa yezokwelapha ehhovisi lenxusa laseKorea. Uma i-visa isilungile siyakusiza futhi sikuqondise ekulungiseleleni amathikithi ohambo nendiza. Siphinde sihlele ihhotela lakho nendlu yezivakashi, uma kudingeka eSouth-Korea. Lapho ufika edolobheni lokwelapha ummeleli wethu uzokwamukela esikhumulweni sezindiza.
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.
Izibhedlela eziphezulu ze-CAR T-Cell therapy e-Korea
Isikhungo sezokwelapha sase-Asan
I-Asan Medical Centre yaseNingizimu Korea ibihamba phambili ekusebenziseni ubuchwepheshe obusha ukwelapha umdlavuza wegazi, ngenhloso yokuthuthukisa imiphumela yesiguli kanye nezinga lempilo. Lesi sikhungo sitshale kubuchwepheshe obusezingeni eliphezulu njengokulandelanisa kwesizukulwane esilandelayo (i-NGS) ukuthola imephu enembile yofuzo yamathumba, okwenza kube nokwenzeka ukwelapha isiguli ngasinye. I-Asan Medical Center iphinde yengeza izindlela zokwelapha ezintsha, ezifana ne-CAR T cell therapy, esebenzisa amasosha omzimba esiguli ukuhlasela amangqamuzana omdlavuza. Lawa mathuluzi ashintshe indlela umdlavuza wegazi otholakala ngayo, ulandelelwa, futhi welashwa ngayo, enikeza iziguli ithemba elisha nokwenza i-Asan Medical Centre ibe umholi ekulweni nomdlavuza wegazi.
Zithini izindleko zokwelashwa kwe-CAR T-Cell eKorea?
Izindleko zokwelashwa kwe-CAR T-Cell eNingizimu-Korea ziqala ukusuka ku-$450,000 USD futhi zingafinyelela ku-$500,000 USD kuye ngohlobo nobungako besifo kanye nomthwalo waso emzimbeni. Kubalulekile ukukhumbula ukuthi lesi silinganiso siwukuqagela nje okuvamile nokuthi izimo ezithile zingase zishintshe. Uhlobo olunembile lokwelashwa kwe-CAR-T, ukuxaka kwenqubo, izindleko zesibhedlela, ukunakekelwa okusekelayo, kanye nokuhlolwa okwengeziwe kokuxilonga konke okuguquguqukayo okungathinta intengo. Ukulawula izindleko ezihlobene nokwelashwa kwamaseli e-CAR-T, kuyalulekwa ukuthi iziguli zikhulume nochwepheshe bezokunakekelwa kwempilo futhi zibheke ukuhlinzekwa komshwalense noma izinhlelo zosizo lwezezimali.
Kuyini ukwelashwa kwe-CAR T-Cell?
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 ukwelashwa kwe-CAR T-Cell?
Uma isetshenziselwa ukwelapha izifo ezithile zegazi njenge-acute lymphoblastic leukemia (ALL) kanye nezinhlobo ezithile ze-lymphoma, ukwelashwa kwe-CAR T-cell 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. I-CAR T-cell therapy inamandla okushintsha ubuso bokwelashwa komdlavuza futhi inikeze iziguli yonke indawo ithemba elisha ngentuthuko eyengeziwe.
Inqubo
Inqubo yokwelapha i-CAR-T, ethatha amasonto ambalwa, ibandakanya izinyathelo eziningi:
Ama-T cell akhishwa egazini lakho kusetshenziswa ishubhu elifakwa emthanjeni wengalo. Lokhu kuthatha amahora ambalwa.
Ama-T cell athuthelwa endaweni lapho enza khona ukuguqulwa kofuzo ukuze abe amaseli e-CAR-T. Kudlula amasonto amabili kuya kwamathathu kukho konke lokhu.
Amangqamuzana e-CAR-T abuyiselwa egazini lakho nge-drip. Lokhu kudinga amahora ambalwa.
Amaseli e-CAR-T aqondisa futhi aqede amangqamuzana omdlavuza kuwo wonke umzimba. Ngemva kokuthola ukwelashwa kwe-CAR-T, uzobhekwa eduze.
Hlobo luni lwamaseli omdlavuza olungelashwa nge-CAR-T Cell Therapy?
Iziguli kuphela ezine-B-cell non-lymphoma Hodgkin's noma i-pediatric acute lymphoblastic leukemia esezizame izindlela zokwelapha ezivamile ezimbili 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 kanye nomdlavuza womlomo.
Ukuphetha
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 + 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 ukwelashwa ngamakhemikhali okungenani izinyanga eziyisithupha noma ngaphezulu.
Izinzuzo zokwelashwa kwe-CAR T-cell, empeleni okuwumuthi ophilayo, zingaphikelela iminyaka eminingi. Uma futhi kwenzeka ukuphindeka, amaseli asazokwazi ukukhomba 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 ngabamukeli abahle be-CAR-T Cell Therapy?
Iziguli ezineminyaka ephakathi kwemi-3 kuya kwengu-70 zizanyiwe nge-CAR T-Cell yokwelapha izinhlobo ezahlukene zomdlavuza wegazi futhi kutholakale ukuthi iyasebenza 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.
Kusebenza kahle kangakanani ukwelashwa kwamaseli e-CAR-T?
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 kubonise ukuthi kuyindlela ephumelela kakhulu yokwelapha ezinye izinhlobo zomdlavuza wegazi. Noma kuyindlela ethembisayo nenamandla, ucwaningo olwengeziwe 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.
Imibandela yokufakwa nokukhipha
Indlela yokufakwa yokwelashwa kwe-CAR T-cell:
1. Iziguli ezine-CD19 + B-cell Lymphoma (Okungenani ama-regimens we-2 chemotherapy ngaphambi kokuhlanganiswa)
2.Ukuba neminyaka eyi-3 kuye kwengama-75
3. Isilinganiso se-ECOG ≤2
4. Abesifazane abanamandla okuthola izingane kumele bathathwe ukuhlolwa komchamo wokukhulelwa futhi kutholakale ukuthi abanalo ngaphambi kokwelapha. Zonke iziguli ziyavuma ukusebenzisa izindlela ezithembekile zokuvimbela inzalo ngesikhathi sesilingo kuze kube kulandelwa okokugcina.
Imibandela yokungafakwa yokwelashwa kwe-CAR T-cell:
1.Ukuphakama komfutho wegazi ophakeme noma ukuquleka
2. Ukwehluleka kokuphefumula
3. Kusatshalaliswe i-coagulation ye-intravascular
4. I-Hematosepsis noma ukutheleleka okusebenzayo okungalawulwa
5. Okungalawulwa isifo sikashukela
Izindlela zokwelapha ze-CAR T-Cell zigunyazwe yi-USFDA
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
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
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
I-B-cell lymphoma ebuyiselwe emuva noma ephikisayo
Izinga lokuphendula eliphelele (CR): 54%
Ithagethi: CD19
Price: $ 410,300
Isikhathi esivunyelwe: Okthoba 18, 2017
I-Myeloma Ephindaphindekayo noma Ephikisayo
Izinga lokuphendula eliphelele: 28%
Ithagethi: CD19
Price: $ 419,500
Kuvunyelwe: Okthoba 18, 2017
Iyini imiphumela emibi yokwelashwa kwe-CAR-T Cell?
Okubalulwe 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 okuphansi kwamangqamuzana egazi, njenge-anemia (isibalo esiphansi samangqamuzana egazi abomvu), i-neutropenia (isibalo esiphansi samangqamuzana egazi amhlophe), kanye ne-thrombocytopenia (isibalo esiphansi seplatelet). Ukutheleleka, ukopha, nokukhathala kuphakathi kwezingozi ezingabhebhethekiswa yilezi cytopenias.
- Amagciwane: Ukucindezela kwe-CAR T-cell therapy kwamangqamuzana omzimba anempilo kwandisa ingozi yokutheleleka ngamagciwane, igciwane, kanye nesikhunta. Ukuze kuvinjwe izifo, iziguli kungase kudingeke ukuthi zibhekwe ngeso elibukhali futhi zinikezwe imithi yokuzivikela.
- I-Tumor Lysis Syndrome (TLS): Ngemva kokwelashwa kwe-CAR T-cell, kwezinye izimo kuyenzeka ukuthi amanani amakhulu wokuqukethwe kweseli akhishelwe egazini 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 eziningi, 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 uqedele inqubo yokwelapha ye-CAR T-Cell. Nakuba isikhathi sincike kakhulu ebangeni lelebhu esuka esibhedlela elungise i-CAR.
- Ukuhlolwa nokuhlolwa: isonto elilodwa
- Ukwelashwa kwangaphambili & Ukuqoqwa kwe-T-Cell: isonto elilodwa
- Ukulungiswa kwe-T-Cell nokubuyisela: amasonto amabili-amathathu
- Ukuhlaziywa kwe-1st Ukusebenza kahle: amaviki amathathu
- Ukuhlaziywa kwe-2nd Ukusebenza kahle: amaviki amathathu.
Isikhathi esiphelele: 10-12 Amaviki