Muna Nyamavhuvhu 2025, Center for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yakapa zviri pamutemo Breakthrough Therapy Designation kuIna-cel, mushonga mutsva weCAR-T cell therapy wakagadzirwa neCD19 wakazvimirira neJuventas, wekurapa varwere vevana vane B-cell acute lymphoblastic leukemia (r/r B-ALL) inodzokera shure kana kuti isingashande.
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
Inaticabtagene autoleucel (Inati-cel) chigadzirwa cheCD19-specific chimeric antigen receptor (CAR) T-cell, chine CD19 scFv inobva ku clone HI19α uye 4-1BB/CD3-ζ costimulatory domain, iyo yakatenderwa muChina kuvarwere vakuru vane relapse or refractory B-acute lymphoblastic leukemia (r/r B-ALL) muna Mbudzi 2023.
IyoMusangano weGore negore weASCO wa2025 mushumo Chidzidzo chenyika chaiyo che multi-center, chisingapindire (NCT06450067) chekuongorora Inati-cel yevarwere vakuru veB-ALL. Pakati paMbudzi 20, 2023, naMbudzi 13, 2024, varwere makumi matanhatu nevaviri vakagamuchira Inati-cel uye vakaongororwa. Zera repakati raive makore makumi matatu nemanomwe (makore gumi nemana kusvika makumi manomwe nematanhatu), nevarwere gumi nevatatu vane makore anopfuura makumi matanhatu. Pakuongororwa, varwere gumi nematanhatu vakadzoka mushure mekuiswa kwemasero eropa (HSCT), varwere vana vaive vasina simba, uye vanopfuura makumi manomwe muzana vevarwere vaive nehutachiona hwakanyanya. Muyero wepakati wekuisa mushonga waive 0.60 (muyero: 0.46-0.9) ×10Masero ari mupenyu e8CAR-T.
Mhedzisiro: Data kubva musi wa30 Zvita, 2024, neavhareji yekutevera kwemwedzi 3.8 (nguva: mwedzi 0.5–12.4), 89.5% vakawana MRD-negative ORR mushure meInati-cel muvarwere veR/R, kusanganisira 31 vane CR uye 3 vane CRi (tafura 1). Varwere vapfumbamwe vane MRD-positive pakuongororwa, MRD-negativity rate yakasvika 100% mushure meInati-cel. Mushure meInati-cel, varwere 26 vakawana MRD results ne q-PCR, uye 92.3% vakawana negative results. Mushure meCR/CRi, varwere vana vakazopedzisira vapihwa allo-HSCT mukuregererwa. Avhareji yeDOR, OS neRFS haina kusvikwa nevarwere uye isina kuvharwa paAllo-HSCT yakatevera. Pakati pevarwere vakaongororwa, RFS yegore rimwe chete neDOR rates yaive 76.2% uye 74.1%, zvichiteerana. Varwere vanomwe vakadzokera kuchirwere zvakare, kusanganisira kudzoka kwechirwere katatu kubva kuCD19+, kudzoka kwechirwere kaviri kubva kuCD19, uye 2 vasina mamiriro eCD19 asina kujeka. Zvakakosha kuziva kuti muzviitiko zvitanhatu zvechirwere chekunze kwemedullary, zviitiko zvina zvakashanda, asi zviitiko zviviri zvakadzokera kuchirwere zvakare mukati memwedzi mitatu mushure meInati-cel. Varwere vese vakagamuchira Inati-cel infusion vaive vapenyu, kunze kwerufu rumwe chete nekuda kwekufambira mberi kwechirwere. Zviitiko zvakaipa (AEs) zvinonyanya kufarirwa zvaive cytokine release syndrome (CRS) uye immune effector cell-associated neurotoxicity syndrome (ICANS). Makumi mashanu nerimwe muzana evarwere vakarwara neCRS, asi CRS neICANS dzegiredhi rechitatu kana kupfuura dzakangoitika mu3.2% ne1.6% yevarwere, zvichiteerana; varwere vese vanopora vasina zvimwe zviitiko, hapana rufu rwakabatana neAE.
Kushandiswa kweInati-cel mukurapa kwechokwadi kunoratidza kuti chirwere cheB-ALL chevanhu vakuru chine MRD yakawanda. Kuchengetedzwa kwacho kwaikwanisika, nehuwandu hushoma hweCRS neICANS hwakawanikwa mukurapa kwechokwadi. Ruzivo rwakareba rwekutevera rucharatidzwa.
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-26-2025