Ngo-Agasti 2025, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) linike ngokusemthethweni i-Breakthrough Therapy Designation kwi-Ina-cel, unyango olutsha lwe-CAR-T oluqondiswe kwi-CD19 olwaphuhliswa ngokuzimeleyo yiJuventas, ukuze kunyangwe izigulana zabantwana ezine-B-cell acute lymphoblastic leukemia (r/r B-ALL) ephinde yabuyela kwi-relaxative okanye enganyangekiyo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
I-Inaticabtagene autoleucel (Inati-cel) yimveliso ye-CD19-specific chimeric antigen receptor (CAR) T-cell, ene-CD19 scFv ethathwe kwi-clone HI19α kunye ne-4-1BB/CD3-ζ costimulatory domain, eyavunywa eTshayina kwizigulana zabantu abadala abane-relapse okanye i-refractory B-acute lymphoblastic leukemia (r/r B-ALL) ngoNovemba ka-2023.
IIntlanganiso Yonyaka ye-ASCO ka-2025 ingxelo uphando lwehlabathi lokwenyani oluneziko ezininzi, olungangeneleliyo (NCT06450067) lokuvavanya i-Inati-cel kwizigulane ze-B-ALL zabantu abadala. Phakathi koNovemba 20, 2023, kunye noNovemba 13, 2024, izigulane ezingama-62 zafumana i-Inati-cel kwaye zavavanywa. Ubudala obuphakathi babuyiminyaka engama-37.5 (ubude, 14-76), kunye nezigulane ezili-13 ezineminyaka eyi-≥60. Ngexesha lokuhlolwa, amatyala ali-16 aphinde abuya emva kokufakelwa kweeseli ze-hematopoietic stem cell (HSCT), amatyala ama-4 ayengachaphazeli kakuhle, kwaye ngaphezulu kwama-70% ezigulane zazinokukhubazeka kwemfuza okunobungozi obukhulu. Idosi ephakathi yokufunxa yayiyi-0.60 (ubude: 0.46-0.9) ×10Iiseli eziphilayo ze-8CAR-T.
Iziphumo: Idatha ukusukela nge-30 kaDisemba 2024, kunye nokulandelela okuphakathi kweenyanga ezi-3.8 (uluhlu: iinyanga ezi-0.5–12.4), i-89.5% ifumene i-MRD-negative ORR emva kwe-Inati-cel kwizigulane ze-r/r, kuquka ezingama-31 ezine-CR kunye nezi-3 ezine-CRi (itheyibhile 1). Izigulane ezilithoba ezine-MRD-positive ngexesha lokuhlolwa, izinga le-MRD-negativity lifikelele kwi-100% emva kwe-Inati-cel. Emva kwe-Inati-cel, izigulane ezingama-26 zafumana iziphumo ze-MRD nge-q-PCR, kwaye i-92.3% yafumana iziphumo ezingezizo. Emva kokufumana i-CR/CRi, izigulane ezi-4 emva koko zafumana i-allo-HSCT ekuxolelweni. I-DOR ephakathi, i-OS kunye ne-RFS azikafikelelwa kunye nezigulane ezivavanyiweyo kwi-allo-HSCT elandelayo kwaye ngaphandle kokuhlolwa. Phakathi kwezigulane ezivavanyiweyo, amazinga e-RFS kunye ne-DOR onyaka omnye ayeyi-76.2% kunye ne-74.1%, ngokwahlukeneyo. Izigulana ezisixhenxe ziye zaphinda zabuyela kwisifo, kuquka ukuphinda zibuyele kwi-CD19+ izihlandlo ezi-3, ukuphinda zibuyele kwi-CD19 izihlandlo ezi-2, kunye nezi-2 ezingenayo imeko engacacanga ye-CD19. Kubalulekile ukuqaphela ukuba kwiimeko ezi-6 zesifo esingaphandle kwe-medullary, iimeko ezi-4 zisebenze kakuhle, kodwa iimeko ezi-2 ziye zaphinda zabuyela kwisifo kwiinyanga ezi-3 emva kwe-Inati-cel. Zonke izigulana ezifumene i-Inati-cel infusion beziphila, ngaphandle kokufa komntu omnye ngenxa yokuqhubela phambili kwesifo. Ezona ziganeko zixhaphakileyo (ii-AE) zinomdla kakhulu yayiyi-cytokine release syndrome (i-CRS) kunye ne-immune effector cell-associated neurotoxicity syndrome (i-ICANS). Amashumi amahlanu ananye ekhulwini ezigulana ziye zafumana i-CRS, kodwa i-CRS kunye ne-ICANS zebanga lesi-3 okanye ngaphezulu zenzeke kuphela kwi-3.2% kunye ne-1.6% yezigulana, ngokwahlukeneyo; zonke izigulana ziyaphola ngaphandle kweziphumo ezilandelayo, akukho kufa okunxulumene ne-AE.
Ukusetyenziswa kwe-Inati-cel ngokwenene kubonisa i-ORR ephezulu engeyiyo i-MRD kwi-B-ALL yabantu abadala. Iprofayili yokhuseleko yayilawuleka, kunye nenani eliphantsi le-CRS kunye ne-ICANS zebanga eli-≥3 kwimeko yokwenyani. Idatha ende yokulandelela iya kuboniswa.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Ixesha leposi: Agasti-26-2025