I-Zevor-cel ivunyiwe ukuba idweliswe

Ngomhla woku-1 kweyoKwindla, ngowama-2024, i-China National Medical Products Administration (NMPA) yavuma ukuqaliswa kwemveliso yeseli ye-CAR-T iZevorcabtagene AutoLeucel (Zevor-cel, CT053) kunyango lwabantu abadala abane-myeloma ephinde yabuyela kwisimo sayo okanye enganyangekiyo abaye baqhubeka emva kweendlela ezintathu zonyango (kusetyenziswa ubuncinane i-proteasome inhibitor kunye ne-immune modulator).

Olu luhlu lusekelwe ikakhulu kuvavanyo lweklinikhi oluvulelekileyo, olungalo lunye, oluneziko elininzi lwesigaba sesiBini (LUMMICAR STUDY 1,NCT03975907) eTshayina, efikelele kwizinga lokuxolelwa eliyi-100%.

Izigulane ezili-14 ezineminyaka ephakathi kwama-54 (uluhlu: 34-62), zafumana i-zevor-cel enye. Ukusukela nge-17 kaJulayi 2023, ixesha eliphakathi lokulandelela yayiziinyanga ezingama-37.7 (uluhlu: 14.8-44.2 iinyanga). Izinga lokuphendula lilonke (ORR) yayiyi-100% (14/14) kunye nezigulane ezingama-78.6% (11/14) ezifumene impendulo epheleleyo (CR) okanye impendulo epheleleyo eqinileyo (sCR); ukungabi namdla kwesifo esincinci esisele (MRD) kufunyenwe kuzo zonke izigulane ezifumene i-CR okanye i-sCR. Ubude bexesha eliphakathi lokuphendula (mDOR) yayiziinyanga ezingama-24.1 kuzo zonke izigulane kunye neenyanga ezingama-26.0 kwabo bafumana i-CR okanye i-sCR. Ukusinda okuphakathi okungenankqubela phambili (mPFS) yayiziinyanga ezingama-25.0. Izigulane ezisi-7 (50%) zazisele zixolelwe ixesha elide kuneenyanga ezingama-24. Umlinganiselo wokusinda jikelele (OS) awuzange ufikelelwe, kwaye ama-92.9% (13/14) ezigulana zazisaphila kwinyanga yama-36.

ukhuseleko
Lilonke, iprofayili yokhuseleko lwe-zevor-cel yayilawuleka. Akukho ziganeko ze-≥ ze-cytokine release syndrome (CRS) zeBanga lesi-3. Akukho ziganeko ze-immune effector cell-associated neurotoxicity syndrome (ICANS) zalo naliphi na inqanaba. Kubonwe usulelo oluthathu olunxulumene nonyango lweBanga lesi-3. Izigulana ezintathu zenzeka iziganeko ezimbi kakhulu (SAE) kuquka izigulana ezi-2 ezazine-SAEs ezinxulumene nonyango ezaziyi-pulmonary infection kunye ne-tumor lysis syndrome. Kukho ukufa kwabantu aba-2 kuphando; akukho nanye eyayinxulumene ne-zevor-cel.

Isiphelo
I-zevor-cel ibonakalise iprofayili yokhuseleko ekhuthazayo ngeempendulo ezinzulu nezihlala ixesha elide ezihambelana neziphumo zokuqala.

Okwangoku, kukho ezinye iimvavanyo ezininzi zeklinikhi ze-CAR-T eTshayina, kwaye zikhangela izigulane. Ukuze ufumane iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region International: 4008803716.

Iireferensi

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