Zevor-cel e amohetsoe bakeng sa ho thathamisoa

Ka la 1 Tlhakubele, 2024, Tsamaiso ea Naha ea Lihlahisoa tsa Bongaka ea Chaena (NMPA) e amohetse ho qalisoa ha sehlahisoa sa sele ea CAR-T Zevorcabtagene AutoLeucel (Zevor-cel, CT053) bakeng sa kalafo ea bakuli ba baholo ba nang le myeloma e mengata e khutlileng kapa e sa laoleheng ba neng ba tsoetse pele ka mor'a bonyane mela e 3 ea kalafo (ho sebelisoa bonyane proteasome inhibitor e le 'ngoe le immune modulator).

Lenane lena le thehiloe haholo-holo tekong ea bongaka ea mohato oa II oa leibole e bulehileng, ea letsoho le le leng, ea libaka tse ngata (THUTO EA LUMMICAR 1,NCT03975907) Chaena, e fihletseng sekhahla sa phokotso ea 100%.

Bakuli ba 14 ba lilemo tse mahareng tsa 54 (sebaka: 34-62), ba ile ba fuoa ente e le 'ngoe ea zevor-cel. Ho tloha ka la 17 Phupu, 2023, nako e mahareng ea tlhahlobo e ne e le likhoeli tse 37.7 (sebaka: likhoeli tse 14.8-44.2). Sekhahla sa karabelo ka kakaretso (ORR) e ne e le 100% (14/14) ka bakuli ba 78.6% (11/14) ba fumaneng karabelo e felletseng (CR) kapa karabelo e tiileng e felletseng (sCR); ho se nepahale ha bonyane ba lefu le setseng (MRD) ho ile ha fihleloa ho bakuli bohle ba fumaneng CR kapa sCR. Nako e mahareng ea karabelo (mDOR) e ne e le likhoeli tse 24.1 ho bakuli bohle le likhoeli tse 26.0 ho ba fumaneng CR kapa sCR. Nako e mahareng ea ho phela ntle le tsoelo-pele (mPFS) e ne e le likhoeli tse 25.0. Kakaretso ea bakuli ba 7 (50%) ba ne ba le phomolong e telele ho feta likhoeli tse 24. Palo e mahareng ea ho phela ka kakaretso (OS) ha ea ka ea fihlelloa, 'me 92.9% (13/14) ea bakuli ba ne ba ntse ba phela khoeling ea 36.

Polokeho
Ka kakaretso, boemo ba polokeho ba zevor-cel bo ne bo laoleha. Ho ne ho se na liketsahalo tsa ≥ cytokine release syndrome (CRS) tsa Sehlopha sa 3. Ho ne ho se na liketsahalo tsa immune effector cell-associated neurotoxicity syndrome (ICANS) tsa sehlopha sefe kapa sefe. Ho bonoe tšoaetso tse tharo tse amanang le kalafo ea Sehlopha sa 3. Bakuli ba bararo ba bile le liketsahalo tse mpe tse tebileng (SAE) ho kenyeletsoa bakuli ba 2 ba neng ba e-na le li-SAE tse amanang le kalafo e leng tšoaetso ea matšoafo le tumor lysis syndrome. Ho bile le mafu a 2 ka kakaretso thutong; ha ho le e 'ngoe ea tsona e neng e amana le zevor-cel.

Qetello
zevor-cel e bontšitse boemo bo khothatsang ba polokeho ka likarabo tse tebileng le tse tšoarellang tse lumellanang le liphetho tsa pele.

Hona jwale, ho na le diteko tse ding tse ngata tsa bongaka tsa CAR-T Chaena, mme di batla bakudi. Bakeng sa ditherisano mabapi le meriana le mahlale a matjha, o ka ikopanya le Lefapha la Matjhaba la Sepetlele sa Oncology sa Beijing Region South Region: 4008803716.

Litšupiso

1.https://www.carsgen.com/cn/

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