Musi wa30 Chikunguru, National Medical Products Administration (NMPA) yakabvumidza zviri pamutemo kutengeswa kweHICARA kwekurapa varwere vakuru vane relapse or refractory large B-cell lymphoma (r/r LBCL) avo vakagamuchira nzira mbiri kana kupfuura dzekurapa systemic. Izvi zvinosanganisira diffuse large B-cell lymphoma, isina kutaurwa neimwe nzira (DLBCL, NOS); diffuse large B-cell lymphoma yakachinjwa kubva ku follicular lymphoma; high-grade B-cell lymphoma ine MYC neBCL2 rearrangements; uye high-grade B-cell lymphoma, isina kutaurwa neimwe nzira (HGBL, NOS).
Izvi zvinoratidza chigadzirwa chekutanga cheCD19 CAR-T chakagadzirwa zvizere muChina chakanangana neB-cell lymphoma yakakura inodzokera shure kana kuti isingashande (r/r LBCL). Tsvagiridzo, kuvandudzwa, uye kugadzirwa kweHICARA zvinotsamira zvizere pakugadzirwa kwemamorekuru kweHrain Biotechnology, sisitimu yemhando yepamusoro yakagadzirwa yakazvimirira, uye chikuva chekugadzira chakavharika, chakakura. Kubudirira uku kunoita kuti kugadzirwa kwemasero eCAR-T kuve kwakazara, zvichiputsa tekinoroji yekune dzimwe nyika. Zvinonyanya kukosha, HICARA ndiyo chigadzirwa chekutanga cheCAR-T chakatenderwa munyika kutora maitiro akagadzikana emasero.
Zvichienderana nemhedzisiro yemuyedzo wePhase II HRAIN01-NHL01-II (NCT05436223) wakapihwa panguva yeMusangano weGore weAmerican Association for Cancer Research (AACR) we2024, HICARA yakaratidza mhinduro dzinoshanda muvarwere vane relapse/refractory non-Hodgkin lymphoma.
Mhedzisiro: Kubva musi wa16 Chivabvu, 2023, varwere 81 veR/R NHL vane ECOG 0-1 pakutanga vakagamuchira infusion HR001 kubva kuJinshan manufacturing facility [51.9% varume; avhareji yezera remakore 53.4 (avhareji ye23~74); 3.7% CD19 negative; 91.4% diffuse large B-cell lymphoma; 79.0% III-IV yeAnn Arbor classification kana Lugano] neavhareji yekutevera kwemazuva 160 (avhareji ye7 kusvika 454). Avhareji yenguva yekupindura kwakanakisa yaive mazuva 30 (avhareji ye28-358). Mwedzi mitatu, mwedzi mitanhatu uye mwero wemhinduro yakanakisisa (ORR) waive 53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) uye 74.1% (95% CI: 63.1-83.2) zvichiteerana. Mwedzi mitatu, mwedzi mitanhatu uye mwero wemhinduro yakakwana yakakwana (CRR) waive 32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) uye 49.4% (95% CI: 38.1-60.7) zvichiteerana. Nguva yepakati yekupindura (DOR) uye yehupenyu husina kuenderera mberi (PFS) yaive mazuva 339 (95% CI: 149-NE) uye mazuva 176 (95% CI: 91-NE) zvichiteerana. Hupenyu hwese (OS) hahuna kusvikwa. Zviitiko zvakanyanya kukanganiswa zvine chekuita nekurapwa (AEs) zvakaitika muropa. Cytokine release syndrome (CRS) yakaitika mu95.1% yevarwere, ne ≥3 grade CRS yakaonekwa mu3.7% yevarwere. Immune effector cell-associated neurotoxicity syndrome (ICANS) yakaitika mu8.6% yevarwere, pasina ≥3 grade ICANS yakashuma. Huwandu hwerufu hune chekuita nekurapwa hwaive 1.2%. Nguva yepakati kusvika pakukura kwemasero eCAR T yaive maawa 240 (120~672) mushure mekuisirwa, kuwedzera kwepakati (Cmax) kwaive 17413.9 copies/μg DNA (124.9~136382.2), uye AUC yepakati.0-28dyaive 3201014.0 makopi/μg DNA (205082.8~18400016.2). Kuongororwa kwakanaka kweanti-drug antibody (ADA) kwakaonekwa mu14.8% yevarwere, ukuwo kuongororwa kweneutralizing antibody (Nab) kwakaonekwa mu3.7% yevarwere. Pakati pevarwere vane Nab-positive, mhinduro yakazara yakaramba iripo kusvika vatevera.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department. Phone Number：4008803716 WeChat ID: 17801183037 Email：myimmnet@163.com
Nguva yekutumira: Chikunguru-31-2025