Ngomhlaka-1 Mashi 2024, i-China National Medical Products Administration (NMPA) yavuma ukwethulwa komkhiqizo weseli ye-CAR-T i-Zevorcabtagene AutoLeucel (Zevor-cel, CT053) yokwelapha iziguli ezindala ezine-myeloma ephindaphindayo noma engaphikisiwe eseziqhubekele phambili ngemuva kwemigqa emithathu yokwelashwa (kusetshenziswa okungenani i-proteasome inhibitor eyodwa kanye ne-immune modulator).
Lolu hlu lusekelwe kakhulu esivivinyweni somtholampilo sesigaba sesi-2 esivulekile, esingalodwa, esinama-centre amaningi (LUMMICAR STUDY 1,NCT03975907) eShayina, ethole izinga lokuxolelwa elingu-100%.
Iziguli ezingu-14 ezineminyaka ephakathi kuka-54 (ububanzi: 34-62), zathola ukumnika okukodwa kwe-zevor-cel. Kusukela ngomhlaka-17 Julayi 2023, isikhathi sokulandelela esimaphakathi sasiyizinyanga ezingu-37.7 (ububanzi: izinyanga ezingu-14.8-44.2). Izinga lokuphendula lilonke (ORR) lalingu-100% (14/14) kanti iziguli ezingu-78.6% (11/14) zathola impendulo ephelele (CR) noma impendulo ephelele eqinile (sCR); ukungezwani okuncane kwesifo esisele (MRD) kwatholakala kuzo zonke iziguli ezathola i-CR noma i-sCR. Isikhathi esimaphakathi sempendulo (mDOR) sasiyizinyanga ezingu-24.1 kuzo zonke iziguli kanye nezinyanga ezingu-26.0 kulabo abathola i-CR noma i-sCR. Ukusinda okumaphakathi okungenakho ukuqhubeka (mPFS) kwakuyizinyanga ezingu-25.0. Iziguli ezingu-7 (50%) zazisele ziphumule isikhathi eside kunezinyanga ezingu-24. Isilinganiso sokusinda okuphelele (OS) asifinyelelwanga, kanti u-92.9% (13/14) weziguli wayesaphila enyangeni engu-36.
Ukuphepha
Sekukonke, iphrofayili yokuphepha ye-zevor-cel yayilawuleka. Bekungekho izehlakalo ze-≥ ze-cytokine release syndrome (CRS) zeBanga lesi-3. Bekungekho izehlakalo ze-immune effector cell-associated neurotoxicity syndrome (ICANS) zanoma yiliphi ibanga. Kubonwe ukutheleleka okuthathu kweBanga lesi-3 okuhlobene nokwelashwa. Iziguli ezintathu zithole izehlakalo ezimbi kakhulu (SAE) okuhlanganisa iziguli ezimbili ezazine-SAEs ezihlobene nokwelashwa okwakuyi-pulmonary infection kanye ne-tumor lysis syndrome. Bekukhona ukufa okungu-2 ocwaningweni; akukho noyedwa owayehlobene ne-zevor-cel.
Isiphetho
i-zevor-cel ibonise iphrofayili yokuphepha ekhuthazayo enezimpendulo ezijulile nezihlala isikhathi eside ezihambisana nemiphumela yokuqala.
Njengamanje, kunezinye izivivinyo eziningi ze-CAR-T eShayina, futhi zifuna iziguli. Ukuze uthole ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela i-Beijing South Region Oncology: 4008803716.
Izinkomba
2.http://sh.news.cn/20240314/2913c85a84be4fbf9345efbd48006971/c.html
3.http://myimm.net/mianyizhiliao/1413.html
4.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240301143753188.html
Isikhathi sokuthunyelwe: Okthoba-31-2024