Na Ọgọst 2025, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) nyere iwu ka a kpọọ Ina-cel, ọgwụgwọ mkpụrụ ndụ CAR-T ọhụrụ nke CD19 duziri nke Juventas mepụtara n'onwe ya, maka ọgwụgwọ nke ndị ọrịa ụmụaka nwere ọrịa leukemia lymphoblastic B-cell nke na-alaghachi azụ ma ọ bụ nke na-anaghị anabata ọgwụgwọ (r/r B-ALL).
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Inaticabtagene autoleucel (Inati-cel) bụ ngwaahịa mkpụrụ ndụ T nke chimeric antigen receptor (CAR) nke CD19-specific, nke nwere CD19 scFv sitere na clone HI19α na 4-1BB/CD3-ζ costimulatory domain, nke akwadoro na China maka ndị ọrịa toro eto nwere ọrịa leukemia lymphoblastic B-acute ma ọ bụ nke na-adịghị ike (r/r B-ALL) na Nọvemba 2023.
IheNzukọ Kwa Afọ nke ASCO nke 2025 akụkọ Nnyocha ụwa dị iche iche (NCT06450067) iji nyochaa Inati-cel maka ndị okenye B-ALL. N'agbata Nọvemba 20, 2023, na Nọvemba 13, 2024, ndị ọrịa 62 natara Inati-cel ma a tụlee ha. Afọ etiti bụ afọ 37.5 (oke, 14-76), yana ndị ọrịa 13 dị afọ ≥60. Mgbe a na-enyocha ha, ikpe 16 laghachiri azụ mgbe a gbasasịrị mkpụrụ ndụ hematopoietic stem transplantation (HSCT), ikpe 4 bụ ndị na-anaghị anabata ọgwụgwọ mbụ, ihe karịrị 70% nke ndị ọrịa nwere nnukwu ihe egwu nke mkpụrụ ndụ ihe nketa. Ọnụọgụ ntinye etiti bụ 0.60 (oke: 0.46-0.9) ×10Mkpụrụ ndụ 8CAR-T dị ndụ.
Nsonaazụ: Data ahụ dị na Disemba 30, 2024, yana nyocha nke etiti nke ọnwa 3.8 (oke: ọnwa 0.5–12.4), 89.5% nwetara MRD-negative ORR mgbe Inati-cel gasịrị n'ime ndị ọrịa r/r, gụnyere 31 nwere CR na 3 nwere CRi (tebụl 1). Ndị ọrịa itoolu nwere MRD-positive mgbe a na-enyocha ha, ọnụego MRD-negativity ruru 100% mgbe Inati-cel gasịrị. Mgbe Inati-cel gasịrị, ndị ọrịa 26 nwetara nsonaazụ MRD site na q-PCR, 92.3% nwetakwara nsonaazụ na-adịghị mma. Mgbe ha nwetasịrị CR/CRi, ndị ọrịa 4 mechara nweta allo-HSCT na mgbaghara. Emebeghị ka DOR, OS na RFS dị n'etiti ha na ndị ọrịa na-enweghị nyocha na allo-HSCT sochirinụ. N'ime ndị ọrịa a na-enyocha, ọnụego RFS na DOR nke afọ 1 bụ 76.2% na 74.1%, n'otu n'otu. Ndị ọrịa asaa nwere nlọghachi azụ, gụnyere nlọghachi CD19+ atọ, nlọghachi CD19 abụọ, na abụọ nwere ọnọdụ CD19 doro anya. Ọ dị mkpa ịmara na n'ime ikpe isii nke ọrịa extramedullary, ikpe anọ dị irè, mana ikpe abụọ laghachiri azụ n'ime ọnwa atọ ka Inati-cel gasịrị. Ndị ọrịa niile natara ọgwụ Inati-cel dị ndụ, ewezuga otu ọnwụ sitere na ọganihu ọrịa. Ihe omume ọjọọ kachasị (AEs) nke nwere mmasị pụrụ iche bụ cytokine release syndrome (CRS) na ọrịa neurotoxicity nke metụtara sel immune effector (ICANS). Pasent iri ise na otu nke ndị ọrịa butere CRS, mana CRS na ICANS nke ọkwa 3 ma ọ bụ karịa mere naanị na 3.2% na 1.6% nke ndị ọrịa, n'otu n'otu; ndị ọrịa niile na-agbake na-enweghị ihe mberede, enweghị ọnwụ metụtara AE.
Ojiji Inati-cel n'ụwa n'ezie na-egosi oke ORR MRD-negative na B-ALL okenye. A na-ejikwa profaịlụ nchekwa ahụ, yana obere ọnụọgụ nke ọkwa ≥3 CRS na ICANS n'ọnọdụ ụwa n'ezie. A ga-egosi data nleba anya ogologo oge.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Oge ozi: Ọgọst-26-2025