Musi wa7 Nyamavhuvhu, Center for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yakazivisa kuti jekiseni rePA3-17 rakapihwa kuti ribatanidzwe mukurapa kwekubudirira, kwakagadzirirwa kurapa varwere vakuru vane relapse/refractory T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL).
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Nhamba yeWeChat: 17801183037
Imeyili：myimmnet@163.com
Varwere vane chirwere cheT-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL) chinodzokera shure/chisingachashandi zvakanaka vanoratidzwa nekurapwa nekukurumidza, kufambira mberi kwechirwere chisina kunaka uye kushaya nzira dzekurapa. Parizvino, Nailabine chete ndiyo yakatenderwa neFDA muna 2005 yekurapa varwere veT-ALL/LBL vasina kupindura kumishonga miviri yechemotherapy kana kuti vakadzokera shure mushure mekurapwa, vaine ORR ye31% uye CR ye23%. Saka, pane chikonzero chekukurumidzira chekugadzira dzimwe nzira dzinoshanda. Kunze kwekuratidzwa kwayo mumasero eT neNK uye kusaratidzwa mune mamwe masero enyama, CD7 inonyanya kuratidzwa mumasero eT-ALL/LBL. Saka, CD7 inoonekwa seimwe nzira inogona kushandiswa pakuvandudza kurapwa kweCAR-T kweT-ALL/LBL. Dambudziko, zvisinei, nderekudzivirira fratricide inokonzerwa nekuratidzwa kweCD7 mumasero eT. Vaongorori vakagadzira jekiseni reCAR-T cell rakavakirwa pama antibodies eCD7 nano, anonzi PA3-17 injection, nekudzivirira kuburitswa kwemorekuru yeCD7 pamusoro pemasero eT kuburikidza ne anti-CD7 protein expression blocker (PEBL).
Ruzivo rwekutevera kwenguva refu kubva mukuyedzwa kwekiriniki kwePhase I yejekiseni rePA3-17 rekurapa relapse/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) rwakaunzwa pamusangano wepasi rose wezvedzidzo EHA 2025.
Kubva musi wa19 Kukadzi, 2025, varwere gumi nevatatu vakanyoreswa (varwere vatatu vari muboka rekutanga, rechipiri, rechitatu, varwere vana vari muboka reRP2D), vese vakapinzwa jekiseni rimwe chete rePA3-17 uye vakapedza kuongororwa kwemazuva makumi maviri nemasere kwedosi inoderedza toxicities (DLTs). RP2D yakasimbiswa pa2×10⁶ CAR-T/kg zvichibva papharmacokinetics, kuchengetedzeka uye kushanda zvakanaka kupfuura dosi iyi. Hapana DLTs dzakaitika uye dosi yepamusoro yakatenderwa (MTD) haina kusvikwa. Kuwanda kweCytokine release syndrome (CRS) kwaive 84.6% (G3:23.1%, hapana G4), nepo immune effector cell-associated neurotoxicity syndrome (ICANS) yakaganhurirwa kuG1-2 (15.4%). Ruzivo rwekushanda zvakanaka rwakaratidza kuti chiyero chakanaka kwazvo chekupindura (ORR) chaive 84.6% (11/13) uye 76.9% (10/13) vakawana kusunungurwa kwakakwana/kusunungurwa kwakakwana nekupora kwehuwandu husina kukwana (CR/CRi). Zvinoshamisa kuti, 69.2% (9/13, varwere 8 CR) vakaramba vachipindura kwemwedzi mitatu, ne50.0% (4/8) vachiramba vaine CR＞mwedzi gumi nemashanu mushure mekuisirwa mushonga pasina kuisirwa stem cell (SCT), uye vaviri vavo vachiri neCAR-T cells dzinoonekwa pamwedzi makumi maviri nerimwe. Zvinonyanya kukosha kuti, murwere akarapwa zvakanyanya [Hematopoietic Stem Cell Transplantation (HSCT) isati yasvika, chirwere chikuru ＞7cm] akawana CR pazuva rechi28 uye wechipiri HSCT pamwedzi mitanhatu.
Jekiseni rePA3-17 rakaratidza kushivirira kwakanaka, kushanda kwakadzama uye kwakasimba mukurapa varwere vane r/r T-ALL/LBL vakarapwa zvakanyanya vasati varapwa, uye 50% yevarwere vane CR vachiri vapenyu kana/uye vasina kufambira mberi kwechirwere mugore rimwe chete.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Nhamba yeWeChat: 17801183037
Email：myimmnet@163.com
Nguva yekutumira: Nyamavhuvhu-13-2025