Na Julaị 30, National Medical Products Administration (NMPA) kwadoro ahịa HICARA maka ọgwụgwọ nke ndị toro eto nwere nnukwu B-cell lymphoma (r/r LBCL) ndị natara usoro ọgwụgwọ sistemụ abụọ ma ọ bụ karịa. Nke a gụnyere nnukwu B-cell lymphoma, nke a na-akọwaghị n'ụzọ ọzọ (DLBCL, NOS); nnukwu B-cell lymphoma nke agbanwere site na follicular lymphoma; nnukwu B-cell lymphoma nke nwere nhazi MYC na BCL2; na nnukwu B-cell lymphoma, nke a na-akọwaghị n'ụzọ ọzọ (HGBL, NOS).
Nke a bụ ngwaahịa CAR-T CD19 nke China mepụtara n'ime obodo mbụ nke na-elekwasị anya na lymphoma B-cell buru ibu nke na-alaghachi azụ ma ọ bụ nke na-adịghị emegharị ahụ (r/r LBCL). Nnyocha, mmepe, na mmepụta nke HICARA dabere kpamkpam na imewe molekul nke Hrain Biotechnology, sistemụ mma usoro nke edobere n'onwe ya, na ikpo okwu mmepụta mechiri emechi, nke buru ibu. Mmezu a na-emezu mmepe na mmepụta mkpụrụ ndụ CAR-T zuru oke, na-emebi ikike teknụzụ mba ofesi. N'ụzọ pụrụ iche, HICARA bụ ngwaahịa CAR-T mbụ a kwadoro n'ime obodo iji nabata usoro vector nje virus nke mkpụrụ ndụ kwụsiri ike.
Dịka nsonaazụ nke nnwale Phase II HRAIN01-NHL01-II (NCT05436223) nke e gosipụtara n'oge nzukọ kwa afọ nke American Association for Cancer Research (AACR) nke 2024 si dị, HICARA gosipụtara mmeghachi omume dị irè n'ahụ ndị ọrịa nwere lymphoma na-adịghị na Hodgkin nke na-alaghachi azụ/na-adịghị eguzogide.
Nsonaazụ: Site na Mee 16, 2023, ndị ọrịa R/R NHL 81 nwere ECOG 0-1 na mmalite natara ọgwụ HR001 site na ụlọ ọrụ mmepụta Jinshan [51.9% nwoke; afọ etiti 53.4 (oke 23-74); 3.7% CD19 negative; 91.4% diffuse nnukwu lymphoma B-cell; 79.0% III-IV nke nhazi Ann Arbor ma ọ bụ Lugano] yana nleba anya etiti nke ụbọchị 160 (oke 7 ruo 454). Oge etiti ruo nzaghachi kacha mma bụ ụbọchị 30 (oke 28-358). Ọnwa 3, ọnwa 6 na ọnụego nzaghachi kacha mma (ORR) bụ 53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) na 74.1% (95% CI: 63.1-83.2) n'otu n'otu. Ọnwa atọ, ọnwa isii na ọnụego nzaghachi zuru oke kacha mma (CRR) bụ 32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) na 49.4% (95% CI: 38.1-60.7) n'otu n'otu. Ogologo oge nzaghachi (DOR) na ndụ na-enweghị ọganihu (PFS) bụ ụbọchị 339 (95% CI: 149-NE) na ụbọchị 176 (95% CI: 91-NE) n'otu n'otu. Erughị ndụ zuru oke (OS). Ihe omume ọjọọ kachasị emetụta ọgwụgwọ (AEs) mere na sistemụ hematologic. Ọrịa ntọhapụ cytokine (CRS) mere na 95.1% nke ndị ọrịa, ebe a hụrụ CRS ọkwa ≥3 na 3.7% nke ndị ọrịa. Ọrịa neurotoxicity nke metụtara mkpụrụ ndụ ihe nketa (ICANS) mere na 8.6% nke ndị ọrịa, na-enweghị akụkọ ICANS ọkwa ≥ 3. Ọnwụ ndị metụtara ọgwụgwọ bụ 1.2%. Oge etiti ruo mgbasa elu mkpụrụ ndụ CAR T bụ awa 240 (120 ~ 672) mgbe etinyere ya, mgbasa kachasị elu (Cmax) bụ 17413.9 kwa μg DNA (124.9 ~ 136382.2), na etiti AUC ...2 ~ 136382.2), na etiti AUC (124.2 ~ 136382.2), na etiti AUC (124.2 ~ 136382).0-28dbụ 3201014.0 copies/μg DNA (205082.8~18400016.2). E hụrụ nnwale dị mma maka antibody anti-drug (ADA) n'ime 14.8% nke ndị ọrịa, ebe nnwale antibody na-adịghị emerụ ahụ (Nab) dị mma n'ime 3.7% nke ndị ọrịa. N'ime ndị ọrịa nwere Nab, a nọgidere na-enweta nzaghachi zuru oke ruo mgbe a ga-enyocha ya.
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
Oge ozi: Julaị-31-2025