Ku ya 1 Werurwe 2024, Ikigo cy’Igihugu cy’Ubushinwa gishinzwe Ibikoresho by’Ubuvuzi (NMPA) cyemeje gutangiza umuti wa selile za CAR-T Zevorcabtagene AutoLeucel (Zevor-cel, CT053) mu kuvura abarwayi bakuru bafite myeloma nyinshi yasubiye inyuma cyangwa yangiritse nyuma y’imirongo itatu y’ubuvuzi (hakoreshejwe nibura umuti umwe wo kwirinda poroteyine n’umuti urinda umubiri).
Uru rutonde rushingiye ahanini ku igerageza ry’ubuvuzi ryakozwe mu cyiciro cya kabiri cy’icyiciro cya kabiri cy’ivuriro rifunguye, rikoresha ukuboko kumwe, kandi rifite amashami menshi (LUMMICAR STUDIY 1,NCT03975907) mu Bushinwa, bwageze ku gipimo cyo kugabanya 100%.
Abarwayi 14 bafite imyaka 54 (urugero: 34-62), bahawe inshinge imwe ya zevor-cel. Kugeza ku ya 17 Nyakanga 2023, igihe cyo gukurikirana cyari amezi 37.7 (urugero: amezi 14.8-44.2). Igipimo rusange cy'ubutabazi (ORR) cyari 100% (14/14) aho abarwayi 78.6% (11/14) babonye igisubizo cyuzuye (CR) cyangwa igisubizo cyuzuye (sCR); indwara ntoya isigara (MRD) yabonetse ku barwayi bose babonye CR cyangwa sCR. Igihe cyo gusubiza (mDOR) cyari amezi 24.1 ku barwayi bose n'amezi 26.0 ku barwayi bose babonye CR cyangwa sCR. Igihe cyo kubaho kidakomeza kwiyongera (mPFS) cyari amezi 25.0. Abarwayi 7 (50%) bose bari mu kiruhuko cy'izabukuru igihe kirenze amezi 24. Igipimo cy’ubuzima rusange (OS) nticyagezweho, kandi 92.9% (13/14) by’abarwayi bari bakiriho ku kwezi kwa 36.
Umutekano
Muri rusange, umutekano wa zevor-cel warashobotse. Nta ndwara ya ≥ cytokine release syndrome (CRS) ya ≥ Grade 3. Nta ndwara ya ICANS (immuno effect cell-associated neurotoxicity syndrome) yagaragaye mu cyiciro icyo ari cyo cyose. Hagaragaye indwara eshatu zandurira mu cyiciro cya 3. Abarwayi batatu bahuye n’ingaruka mbi zikomeye (SAE) barimo abarwayi 2 bari bafite indwara za SAE zijyanye n’ubuvuzi ari zo indwara z’ibihaha na tumor lysis syndrome. Muri rusange hari impfu 2 muri ubwo bushakashatsi; nta n’imwe yari ifitanye isano na zevor-cel.
Umwanzuro
zevor-cel yagaragaje umutekano ushimishije, ifite ibisubizo byimbitse kandi birambye bihuye n'ibyavuye mu bushakashatsi bwa mbere.
Kuri ubu, hari andi magerageza menshi ya CAR-T mu Bushinwa, kandi barimo gushaka abarwayi. Kugira ngo ubone inama ku miti mishya n'ikoranabuhanga, ushobora kuvugana n'Ishami Mpuzamahanga ry'Ibitaro bya Oncology bya Beijing Region South: 4008803716.
Amareferensi
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
Igihe cyo kohereza: Ukwakira-31-2024