A ranar 30 ga Yuli, Hukumar Kayayyakin Lafiya ta Ƙasa (NMPA) ta amince da tallan HICARA a hukumance don maganin manyan marasa lafiya da suka sake komawa baya ko kuma suka yi watsi da babban lymphoma na B-cell (r/r LBCL) waɗanda suka karɓi nau'ikan magani guda biyu ko fiye. Wannan ya haɗa da babban lymphoma na B-cell, wanda ba a ƙayyade shi ba (DLBCL, NOS); babban lymphoma na B-cell wanda aka canza daga follicular lymphoma; babban lymphoma na B-cell tare da sake fasalin MYC da BCL2; da babban lymphoma na B-cell, wanda ba a ƙayyade shi ba (HGBL, NOS).
Wannan ya nuna samfurin CAR-T na CD19 na farko da aka haɓaka a cikin gida a China wanda ke mai da hankali kan babban ƙwayar cutar B-cell lymphoma (r/r LBCL) da ya sake dawowa ko kuma ya sake yin illa. Bincike, haɓakawa, da samar da HICARA sun dogara ne gaba ɗaya akan ƙirar ƙwayoyin halitta ta Hrain Biotechnology, tsarin ingancin tsari wanda aka kafa shi daban-daban, da kuma babban dandamalin samarwa. Wannan nasarar ta cimma cikakken nasarar haɓaka da samar da ƙwayoyin CAR-T, wanda ya karya ikon mallakar fasaha na ƙasashen waje. Abin lura, HICARA ita ce samfurin CAR-T na farko da aka amince da shi a cikin gida wanda ya rungumi tsarin vector na ƙwayoyin cuta na layin ƙwayoyin cuta mai ɗorewa.
Dangane da sakamakon gwajin Phase II HRAIN01-NHL01-II (NCT05436223) da aka gabatar a lokacin taron shekara-shekara na Ƙungiyar Binciken Ciwon daji ta Amurka (AACR) na 2024, HICARA ta nuna ingantattun amsoshi ga marasa lafiya da suka sake kamuwa da cutar lymphoma ba Hodgkin ba.
Sakamako: Ya zuwa ranar 16 ga Mayu, 2023, marasa lafiya 81 na R/R NHL da ke dauke da ECOG 0-1 a farkon allurar sun sami jiko na HR001 daga cibiyar masana'antar Jinshan [51.9% na maza; matsakaicin shekaru 53.4 (tsakanin 23-74); 3.7% na CD19 mara kyau; 91.4% na babban lymphoma na B-cell; 79.0% na III-IV na rarrabuwar Ann Arbor ko Lugano] tare da matsakaicin bin diddigin kwanaki 160 (tsakanin 7 zuwa 454). Matsakaicin lokacin zuwa mafi kyawun amsawa shine kwanaki 30 (tsakanin 28-358). Matsakaicin lokacin amsawar watanni 3, watanni 6 da mafi kyawun ƙimar amsawar manufa (ORR) shine 53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) da 74.1% (95% CI: 63.1-83.2) bi da bi. Matsakaicin tsawon lokacin amsawa na watanni 3, watanni 6 da mafi kyawun ƙimar amsawa (CRR) shine 32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) da 49.4% (95% CI: 38.1-60.7) bi da bi. Matsakaicin tsawon lokacin amsawa (DOR) da rayuwa ba tare da ci gaba ba (PFS) sune kwanaki 339 (95% CI: 149-NE) da kwanaki 176 (95% CI: 91-NE) bi da bi. Ba a kai ga cikakken rayuwa ba (OS). Abubuwan da suka fi faruwa da suka shafi magani (AEs) sun faru ne a cikin tsarin jini. Ciwon sakin cytokine (CRS) ya faru ne a cikin 95.1% na marasa lafiya, inda aka lura da CRS na ≥3 a cikin 3.7% na marasa lafiya. Ciwon neurotoxicity da ke da alaƙa da ƙwayoyin rigakafi (ICANS) ya faru a cikin kashi 8.6% na marasa lafiya, ba tare da rahoton ICANS mai maki ≥3 ba. Mace-macen da ke da alaƙa da magani shine 1.2%. Matsakaicin lokacin faɗaɗa kololuwar ƙwayoyin CAR shine awanni 240 (120 ~ 672) bayan jiko, matsakaicin faɗaɗawa (Cmax) shine kwafi 17413.9/μg na DNA (124.9 ~ 136382.2), kuma matsakaicin AUC0-28dya kasance kwafi 3201014.0/μg DNA (205082.8~18400016.2). An lura da gwaje-gwajen da aka yi wa anti-microbial antibody (ADA) a cikin 14.8% na marasa lafiya, yayin da gwaje-gwajen antibody (Nab) masu hana kamuwa da cuta suka kasance tabbatacce a cikin 3.7% na marasa lafiya. Daga cikin marasa lafiya masu Nab-positive, an ci gaba da cikakken amsawa har sai an bi diddigin su.
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
Lokacin Saƙo: Yuli-31-2025