Zevor-cel kwadoro maka ndepụta

Na Machị 1, 2024, China National Medical Products Administration (NMPA) kwadoro mwepụta nke ngwaahịa mkpụrụ ndụ CAR-T Zevorcabtagene AutoLeucel (Zevor-cel, CT053) maka ọgwụgwọ nke ndị okenye nwere ọrịa myeloma relapsed ma ọ bụ refractory ndị gara n'ihu mgbe ha mechara ọgwụgwọ opekata mpe ugboro atọ (jiri ma ọ dịkarịa ala otu proteasome inhibitor na immunomodulator).

Ndepụta a dabere na nnwale ụlọ ọgwụ nke e ji akara mepere emepe, otu aka, nke nwere ọtụtụ etiti nkebi nke abụọ (LUMMICAR STEM 1,NCT03975907) na China, nke nwetara mbelata 100% na ọnụego ahụ..

Ndị ọrịa iri na anọ nwere afọ etiti nke afọ 54 (nke dị n'etiti ：34-62), natara otu ọgwụ zevor-cel. Dịka ọ dị na Julaị 17, 2023, oge ọgwụgwọ ahụ bụ ọnwa 37.7 (nke dị n'etiti: ọnwa 14.8-44.2). Ọnụọgụ nzaghachi (ORR) n'ozuzu ya bụ 100% (14/14) yana 78.6% (11/14) ndị ọrịa nwetara nzaghachi zuru oke (CR) ma ọ bụ nzaghachi zuru oke siri ike (sCR); e nwetara obere ihe na-adịghị mma nke ọrịa fọdụrụ (MRD) n'ime ndị ọrịa niile nwetara CR ma ọ bụ sCR. Ogologo oge nzaghachi (mDOR) bụ ọnwa 24.1 n'ime ndị ọrịa niile na ọnwa 26.0 n'ime ndị na-enweta CR ma ọ bụ sCR. Nzọpụta ndụ na-enweghị ọganihu (mPFS) bụ ọnwa 25.0. Ngụkọta nke ndị ọrịa 7 (50%) nọ na mgbaghara na-adịru ihe karịrị ọnwa 24. Erughị ọkara ndụ zuru oke (OS) ahụ, 92.9% (13/14) nke ndị ọrịa ka dị ndụ na ọnwa 36.

Nchekwa
N'ozuzu, a na-ejikwa nchekwa nke zevor-cel. Enweghị ihe omume ≥ cytokine release syndrome (CRS) nke ọkwa 3. Enweghị ihe omume immunoeffector cell-associated neurotoxicity syndrome (ICANS) nke ọkwa ọ bụla. A hụrụ ọrịa atọ metụtara ọgwụgwọ nke ọkwa 3. Ndị ọrịa atọ nwere ihe omume ọjọọ dị njọ (SAE) gụnyere ndị ọrịa abụọ nwere SAEs metụtara ọgwụgwọ nke bụ ọrịa akpa ume na ọrịa tumor lysis syndrome. E nwere ọnwụ abụọ n'ozuzu na ọmụmụ ihe ahụ; ọ dịghị nke metụtara zevor-cel.

Mmechi
zevor-cel gosipụtara profaịlụ nchekwa na-agba ume yana azịza miri emi na nke siri ike kwekọrọ na nsonaazụ mbụ.

Ugbu a, enwere ọtụtụ nnwale ụlọ ọgwụ CAR-T ndị ọzọ na China, ha na-achọkwa ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ ọhụrụ na teknụzụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region: 4008803716.

Ntụaka

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