Pa 1 Marichi, 2024, bungwe la China National Medical Products Administration (NMPA) linavomereza kuyambitsidwa kwa mankhwala a maselo a CAR-T Zevorcabtagene AutoLeucel (Zevor-cel, CT053) kuti athandize odwala akuluakulu omwe ali ndi matenda a myeloma ambiri omwe abwereranso kapena omwe sanachiritsidwe omwe adapita patsogolo atatha kulandira chithandizo cha mitundu itatu (pogwiritsa ntchito mankhwala amodzi oletsa proteasome ndi immune modulator).
Mndandanda uwu umachokera makamaka pa mayeso azachipatala a gawo lachiwiri lotseguka, la mkono umodzi, komanso la magawo ambiri (LUMMICAR STUDIY 1,NCT03975907) ku China, komwe kudapeza chiwopsezo cha 100% cha kuchotsedwa kwa kachilomboka.
Odwala 14 azaka zapakati pa 54 (34-62), adalandira jekeseni imodzi ya zevor-cel. Kuyambira pa Julayi 17, 2023, nthawi yapakati yotsatiridwa inali miyezi 37.7 (miyezi 14.8-44.2). Chiwerengero chonse cha mayankho (ORR) chinali 100% (14/14) ndipo odwala 78.6% (11/14) adayankha mokwanira (CR) kapena adayankha mokwanira (sCR); kuchepa kwa matenda otsalira (MRD) kunapezeka mwa odwala onse omwe adalandira CR kapena sCR. Nthawi yapakati yoyankha (mDOR) inali miyezi 24.1 mwa odwala onse ndipo miyezi 26.0 mwa omwe adalandira CR kapena sCR. Kupulumuka kwapakati kopanda kupita patsogolo (mPFS) kunali miyezi 25.0. Odwala onse 7 (50%) anali ndi chikhululukiro chopitilira miyezi 24. Chiwerengero chapakati cha kupulumuka (OS) sichinafike, ndipo 92.9% (13/14) ya odwala anali akadali ndi moyo pa mwezi wa 36.
Chitetezo
Ponseponse, chitetezo cha zevor-cel chinali chotheka. Panalibe zochitika za ≥ Giredi 3 cytokine release syndrome (CRS). Panalibe zochitika za immunoeffector cell-associated neurotoxicity syndrome (ICANS) za giredi iliyonse. Matenda atatu okhudzana ndi chithandizo adawonedwa. Odwala atatu adakumana ndi zochitika zoyipa kwambiri (SAE) kuphatikiza odwala awiri omwe anali ndi matenda okhudzana ndi chithandizo omwe anali matenda a m'mapapo ndi tumor lysis syndrome. Panali anthu awiri omwe anamwalira pa kafukufukuyu; palibe amene anali wokhudzana ndi zevor-cel.
Mapeto
zevor-cel inasonyeza chitetezo cholimbikitsa ndi mayankho akuya komanso okhazikika ogwirizana ndi zotsatira zoyambirira.
Pakadali pano, pali mayeso ena ambiri azachipatala a CAR-T ku China, ndipo akufunafuna odwala. Kuti mudziwe zambiri za mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region: 4008803716.
Zolemba
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
Nthawi yotumizira: Okutobala-31-2024