Fabrairu 2024: Yunkurin farko na kasar Sin wajen samar da sabbin hanyoyin warkar da cutar kansa ya samu karbuwa sosai bayan da aka fara amfani da sinadarin chimeric antigen receptor (CAR-ingineered T-cell (CART) therapy. Multi myeloma, wani mummunan ciwon daji na jini wanda ke da ƙwayoyin plasma masu ɓarna. Wannan sabuwar hanyar tana wakiltar lokacin zubar ruwa a cikin magungunan da aka keɓance, yana ba da bege ga marasa lafiya waɗanda aka iyakance zaɓinsu zuwa yanzu.
Bayanin CAR-T Cell Therapy
CAR T-cell far yana amfani da ƙwayoyin rigakafi na majiyyaci don ganowa da kuma kai hari ga ƙwayoyin kansa waɗanda ke bayyana takamaiman sunadaran. Injiniyoyin waɗannan ƙwayoyin T don haɗa masu karɓa na wucin gadi da aka sani da CARs suna canza su zuwa makaman da aka yi niyya sosai waɗanda ke iya lalata ƙwayoyin ƙari. Lokacin da wani yana da myeloma da yawa, ana canza ƙwayoyin CAR T zuwa BCMA, furotin da ke samuwa a cikin adadi mai yawa a cikin marasa lafiya.
Gwaje-gwaje na asibiti da Sakamako
FUCASO
A cikin 2018, IASO Biotherapeutics da Innovent Biologics sun ƙaddamar da bincike na Phase 1/2 da yawa don kimantawa. equecabtagene autoleucel (FUCASO), Na farko da kasar Sin ta fara yin maganin CAR T-cell a cikin gida. Binciken ya haɗa da mutane 79 tare da myeloma da yawa waɗanda suka ƙare zaɓin zaɓin jiyya. Abin sha'awa shine, jimlar amsawar amsawa (ORR) ta cimma kashi 94.9%, yayin da cikakkiyar amsa / stringent cikakken amsa (CR/sCR) adadin ya kasance 58.2%. Matsakaicin lokacin dawowa da CR/sCR sune kwanaki 16 da kwanaki 95, bi da bi. Waɗannan binciken sun tabbatar da ingantaccen ingancin equecabtagene autoleucel da kuma ingantaccen bayanin martabarsa.
Ga marasa lafiya waɗanda a baya suna da maganin CAR T-cell, ORR ya tashi zuwa 98.5%, tare da samun CR/sCR shida. Musamman ma, majinyacin farko da aka yi masa magani a cikin gwaji ya ci gaba da samun cikakkiyar gafara fiye da watanni 40.
CILTA-CEL far
Cilta-cel, kuma aka sani da ciltacabtagene autoleucel, shine maganin ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar kuma ta CAR (CAR) T-cell magani wanda ke kaiwa B-cell maturation antigen (BCMA), furotin da ke da yawa a cikin ƙwayoyin myeloma masu yawa. Wannan sabon magani ya nuna babban alƙawarin a cikin magance sake dawowa da ƙwayar myeloma mai yawa, yana ba da sabon bege ga marasa lafiya waɗanda suka ƙare hanyoyin maganin gargajiya.
Maganin Cilota-cel yana canza kwayoyin halittar T na majiyyaci don bayyana CARs waɗanda ke ɗaure da BCMA akan ƙwayoyin myeloma. Da zarar an mayar da su cikin majiyyaci, waɗannan ƙwayoyin CAR T da aka canza za su iya yin nasara cikin niyya da lalata ƙwayoyin cuta, wanda ke haifar da koma bayan ƙwayar ƙwayar cuta da yuwuwar gafara na dogon lokaci.
Ingantaccen asibiti
Gwajin asibiti, musamman ma mahimmanci CARTITUDE-1 gwaji, sun nuna cewa cilta-cel yana da ingantaccen inganci a cikin marasa lafiya da aka riga aka yi wa magani da yawa tare da sake dawo da myeloma da yawa. Sakamakon waɗannan gwaje-gwajen sun bayyana ƙimar amsawar gabaɗaya (ORR) na 98%, tare da ɗimbin kaso na marasa lafiya da ke samun cikakkiyar amsa (sCR).
A tsaka-tsakin tsaka-tsakin watanni 28, cilta-cel ya nuna ci gaba mai dorewa, tare da rayuwa marar ci gaba na tsaka-tsaki har yanzu ba a kai ba. Magungunan ya kuma nuna bayanan bayanan lafiya masu ma'ana, tare da samun nasarar gudanar da mummunan al'amuran ta hanyar hanyoyin kulawa.
Kalubale da Dama
Duk da kyakkyawan sakamakon da aka samu, akwai gagarumin kalubale. Yawancin gwaje-gwaje na asibiti a kasar Sin ƙananan ƙananan ne kuma na tsakiya guda ɗaya, tare da rashin isasshen ƙarfi da daidaituwa tsakanin cibiyoyi. Don magance waɗannan hane-hane, dole ne kamfanoni su taka rawar gani sosai a cikin tallan maganin CAR T, tabbatar da cewa yana samuwa ga marasa lafiya.
Bugu da ƙari kuma, ana buƙatar ingantattun hanyoyin masana'antu, tashoshi masu saurin sarrafawa, da ƙarin damar samun haƙuri don tabbatar da cewa an sami nasarar fassara maganin CAR T-cell daga benci na ɗakin gwaje-gwaje zuwa gefen gado. Haɗin kai tsakanin makarantun ilimi, masana'antu, da hukumomin gwamnati suna da mahimmanci don tuki sabbin abubuwa da haɓaka kulawar haƙuri.
Menene haɗarin CAR T-Cell far a cikin marasa lafiya myeloma da yawa?
Abubuwan illa na CAR T-Cell far a cikin myeloma da yawa sun yi kama da wadanda ke cikin cutar sankarar bargo da lymphoma.
Ciwon Sakin Cytokine (CRS) yana daya daga cikin illolin da ake samu na maganin CAR T-cell, yana haifar da alamomi kamar zazzabi, ƙarancin jini, wahalar numfashi, tashin zuciya, da rashes. Yawancin abubuwan da ke faruwa suna da sauƙi, amma masu tsanani na iya yin barazanar rayuwa.
Abubuwan da ke tattare da jijiyoyin jijiya, kamar tada hankali, kamewa, ko wahalar magana da fahimta, na iya zama mai tsanani kuma yana buƙatar saƙon likita cikin gaggawa.
Wasu Mummunan illar illa: Waɗannan na iya haɗawa da martanin rashin lafiyan yayin jiko, tsarin garkuwar jiki da ba shi da kyau, wanda ke ƙara haɗarin kamuwa da cuta, ƙarancin ƙwayoyin jini, da yuwuwar sakamakon tsarin jijiyoyin jini na dogon lokaci.
Don taƙaitawa, yayin da CAR T-cell far yana ba da fa'idodi masu mahimmanci dangane da ƙimar amsawa mai girma da keɓaɓɓen magani ga marasa lafiya na myeloma da yawa, kuma yana ɗauke da haɗari irin su cututtukan saki na cytokine da cututtukan cututtukan ƙwayoyin cuta, waɗanda dole ne a kula da su da kulawa da masu ba da lafiya. . Ana buƙatar kulawa ta kusa bayan farfaɗo don kiyaye amincin haƙuri da haɓaka sakamakon jiyya.
Makasudin gaba
Yayin da kasar Sin ke ci gaba da zuba jari mai yawa a fannin binciken likitanci, ana sa ran fannin kula da kwayar cutar kwayar cutar CAR zai yi girma sosai. Hukumar Kula da Kayayyakin Kiwon Lafiya ta kasar Sin (NMPA) ta amince da alkawarin maganin CAR T-cell ta hanyar ayyana equecabtagene autoleucel a matsayin maganin ci gaba da kuma maganin marayu. Wannan amincewar ta nuna yadda gwamnatin kasar Sin ta himmatu wajen raya manyan ci gaban magani.
Har ila yau, ana kallon equecabtagene autoleucel a matsayin mai yuwuwar magani ga cututtukan cututtukan cututtukan gani na neuromyelitis. Wannan yana nuna cewa ana iya amfani da maganin CAR T-cell don wasu abubuwa banda kansa.
With continuous investment in infrastructure, education, and collaborative relationships, China is well-positioned to lead the way in CAR T-cell far for multiple myeloma and other life-threatening diseases.
Menene farashin CAR T-Cell far na myeloma da yawa a China?
Farashin CAR T-Cell far na myeloma da yawa ya dogara da nau'in CAR T Cell therapy da aka zaɓa da kuma asibitin da aka zaɓa. Kudin jiyya na FUCASO yana kusa da $200,000 USD a asibitoci daban-daban. Farashin maganin CILTA-CEL shima ya bambanta tsakanin $200-250,000 USD. Koyaya, marasa lafiya kuma zasu iya zaɓar CAR T-Cell gwajin gwaji na asibiti wanda zai kasance tsakanin $60-80,000 USD.
