An amince da Zevor-cel don yin rijista

A ranar 1 ga Maris, 2024, Hukumar Kayayyakin Lafiya ta Ƙasa ta China (NMPA) ta amince da ƙaddamar da samfurin ƙwayoyin CAR-T Zevorcabtagene AutoLeucel (Zevor-cel, CT053) don maganin manya marasa lafiya da suka sake kamuwa da cutar myeloma mai yawa waɗanda suka ci gaba bayan aƙalla layuka 3 na magani (ta amfani da aƙalla maganin hana proteasome guda ɗaya da kuma tsarin garkuwar jiki).

Wannan jerin ya dogara ne akan gwajin asibiti mai lakabin buɗewa, hannu ɗaya, da kuma na mataki na biyu mai cibiya da yawa (LUMMICAR DARASI NA 1,NCT03975907) a China, wanda ya cimma kashi 100% na sassaucin da aka samu..

Marasa lafiya 14 waɗanda matsakaicin shekarunsu ya kai shekaru 54 (daga ：34-62), sun sami maganin zevor-cel sau ɗaya. Tun daga ranar 17 ga Yuli, 2023, matsakaicin lokacin da ake bibiya shine watanni 37.7 (daga 14.8-44.2). Jimillar adadin amsawar (ORR) shine 100% (14/14) tare da marasa lafiya 78.6% (11/14) sun sami cikakken amsawar (CR) ko cikakken amsawar (sCR) mai tsauri; an sami ƙarancin rashin lafiyar da ta rage saura (MRD) a duk marasa lafiya da suka sami ko dai CR ko sCR. Matsakaicin tsawon lokacin amsawar (mDOR) shine watanni 24.1 a duk marasa lafiya da kuma watanni 26.0 a cikin waɗanda suka sami CR ko sCR. Matsakaicin rayuwa ba tare da ci gaba ba (mPFS) shine watanni 25.0. Jimillar marasa lafiya 7 (50%) suna cikin sassauci wanda ya fi watanni 24. Ba a kai ga matsakaicin rayuwa gaba ɗaya ba (OS), kuma kashi 92.9% (13/14) na marasa lafiya suna nan da rai a watan 36.

Tsaro
Gabaɗaya, yanayin aminci na zevor-cel ya kasance mai sauƙi. Babu wani abin da ya faru na ≥ cytokine release syndrome (CRS) na ≥ Grade 3. Babu wani abin da ya faru na cutar neurotoxicity syndrome (ICANS) mai alaƙa da ƙwayoyin cuta na rigakafi na kowane mataki. An lura da kamuwa da cuta guda uku da suka shafi magani na Grade 3. Marasa lafiya uku sun fuskanci mummunan abubuwan da suka faru (SAE) ciki har da marasa lafiya 2 waɗanda ke da SAEs masu alaƙa da magani waɗanda suka haɗa da kamuwa da cutar huhu da ciwon daji. An sami mutuwar mutane 2 gaba ɗaya a binciken; babu ɗayansu da ke da alaƙa da zevor-cel.

Kammalawa
zevor-cel ya nuna kyakkyawan yanayin tsaro tare da amsoshi masu zurfi da ɗorewa daidai da sakamakon farko.

A halin yanzu, akwai wasu gwaje-gwajen asibiti da yawa na CAR-T a China, kuma suna neman marasa lafiya. Don neman shawara kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing: 4008803716.

Nassoshi

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