Pa Ogasiti 7, Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA) idalengeza kuti jakisoni wa PA3-17 waperekedwa kuti uphatikizidwe mu njira yochizira matenda, yomwe cholinga chake ndi kuchiza odwala akuluakulu omwe ali ndi T-cell yobwereranso/yosasinthika ya T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL).
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Odwala omwe ali ndi T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL) omwe abwereranso/kukana kuchira amawonetsedwa ndi kupita patsogolo kwa matenda mwachangu, kusakhala bwino kwa matenda komanso kusowa kwa njira zochiritsira. Pakadali pano, Nailabine yekha ndiye adavomerezedwa ndi FDA mu 2005 kuti athandize odwala T-ALL/LBL omwe sanayankhe mankhwala a chemotherapy osachepera awiri kapena omwe adabwereranso atalandira chithandizo, ndi ORR ya 31% ndi CR ya 23%. Chifukwa chake, pali kufunika kofulumira kupanga njira zina zogwira mtima. Kupatula kuwonekera kwake m'maselo abwinobwino a T ndi NK komanso kusawonekera m'maselo ena a minofu, CD7 imawonetsedwa kwambiri m'maselo a T-ALL/LBL. Chifukwa chake, CD7 imaonedwa kuti ndi chandamale chomwe chingapangitse kuti pakhale chithandizo cha CAR-T cha T-ALL/LBL. Komabe, vuto ndikupewa fratricide yomwe imachitika chifukwa cha kuwonekera kwa CD7 m'maselo a T. Ofufuza adapanga jakisoni wa maselo a CAR-T kutengera ma antibodies a nano a CD7, otchedwa jakisoni wa PA3-17, poletsa kuwonekera kwa molekyulu ya CD7 pamwamba pa maselo a T kudzera mu anti-CD7 protein expression blocker (PEBL).
Deta yotsatiridwa kwa nthawi yayitali kuchokera ku mayeso azachipatala a Phase I a jakisoni wa PA3-17 pochiza matenda a relapse/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) idaperekedwa pamsonkhano wapadziko lonse wamaphunziro EHA 2025.
Pofika pa 19 February, 2025, odwala 13 onse adalembedwa (odwala atatu omwe ali mu gulu la 1, 2, 3, odwala 4 omwe ali mu gulu la RP2D), onse omwe adalandira jakisoni imodzi ya PA3-17 ndipo adamaliza kuwunika kwa masiku 28 kwa mlingo woletsa poizoni (DLTs). RP2D idakhazikitsidwa pa 2 × 10⁶ CAR-T/kg kutengera pharmacokinetics, chitetezo ndi mphamvu yoposa mlingo uwu. Palibe DLTs yomwe idachitika ndipo mlingo waukulu wololera (MTD) sunafikire. Kuchuluka kwa Cytokine release syndrome (CRS) kunali 84.6% (G3:23.1%, palibe G4), pomwe immunoeffector cell-associated neurotoxicity syndrome (ICANS) inali yochepa pa G1-2 (15.4%). Deta yogwira ntchito bwino inasonyeza kuti mlingo wabwino kwambiri woyankha (ORR) unali 84.6% (11/13) ndipo 76.9% (10/13) adapeza chikhululukiro chathunthu/chikhululukiro chathunthu ndi kuchira kosakwanira kwa chiwerengero (CR/CRi). Chodabwitsa n'chakuti, 69.2% (9/13, odwala 8 CR) adasungabe yankho pa miyezi itatu, ndipo 50.0% (4/8) adasunga CR＞miyezi 15 atalandira chithandizo popanda kuikidwanso maselo oyamba (SCT), ndipo awiri mwa iwo adali ndi maselo a CAR-T omwe amaonekabe pa miyezi 21. Chochititsa chidwi n'chakuti, wodwala yemwe adachiritsidwa kale [Hematopoietic Stem Cell Transplantation (HSCT) isanachitike, matenda akuluakulu ＞7cm] adapeza CR pofika tsiku la 28 ndipo wachiwiri HSCT pa miyezi 6.
Jakisoni wa PA3-17 unasonyeza kulekerera bwino, kugwira ntchito mozama komanso kosalekeza kwa odwala omwe adalandira chithandizo cha r/r T-ALL/LBL omwe anali atalandira chithandizo chamankhwala kwambiri, ndipo 50% ya odwala a CR adapulumuka kapena/ndipo alibe kupita patsogolo kwa matendawa chaka chimodzi.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Chizindikiro cha WeChat: 17801183037
Email：myimmnet@163.com
Nthawi yotumizira: Ogasiti-13-2025