NgoMashi 2024, ukukhishwa kwezindaba kusho ukuthi i-A2B530 (A2 Biotherapeutics), i-CAR T-cell therapy, inikezwe i-Orphan Drug Designation yokwelapha umdlavuza we-colorectal oveza i-carcinoembryonic antigen (CEA) futhi ilahlekelwe ukubonakaliswa kwe-HLA-A*02 kubantu abanamagciwane. i-heterozygous HLA-A*02(+) isifo.
Abacwaningi bacabanga ukuthi i-autologous logic-gated cell therapy ingakhomba amaseli e-tumor ngenkathi ivikela izicubu ezinempilo. Lokhu kungenxa yokuthi ineswishi yokuphepha eyakhelwe ngaphakathi engagcina izicubu ezinempilo zingalimali. Esifundweni sesigaba 1/2 EVEREST-1 (NCT05736731), lo mbono uzohlolwa.
Ungahle uthande ukufunda: Ukwelashwa kwe-CAR T-Cell eChina
Isinqumo se-FDA sokunikeza i-Orphan Drug Designation siqinisekisa isidingo esikhulu esingahlangatsheziwe sokwelashwa okungcono kubantu abane umdlavuza wesisu,” kusho uWilliam Go, MD, PhD, isikhulu sezokwelapha i-A2 Bio, enkulumweni yezindaba. Lokhu kuqokwa kusekela isithembiso sethu sokusebenzisa inkundla yethu yobuchwepheshe obusezingeni eliphezulu ukudala umdlavuza omusha zokwelapha kubantu abanomdlavuza okunzima ukuwelapha.
Ilebula evulekile, isigaba 1/2 socwaningo lwe-EVEREST-1 lubheka i-A2B530 njengendlela yokwelapha engenzeka yamathumba aqinile njengomdlavuza we-colorectal, umdlavuza we-pancreatic, kanye umdlavuza wamaphaphu weselula ongewona omncane. Iphinde ibheke ezinye izinhlobo zezimila eziqinile ezikhiqiza i-CEA kodwa hhayi i-HLA-A*02. Abantu manje asebesocwaningweni lwe-EVEREST-1 baqale ocwaningweni lwe-BASECAMP-1 (NCT04981119), lapho ama-T cell abo aqoqwa khona, acutshungulwa, futhi agcinwa ukuze asetshenziswe kamuva.
Ungahle uthande ukufunda: Ukwelashwa kwe-CAR T-Cell ye-myeloma eminingi e-China
Umgomo oyinhloko wocwaningo lwesigaba 1 ukuthola umthamo ophephe kakhulu futhi osebenza kahle kakhulu. Ukuphepha nokusebenza ngempumelelo kufanele kugcinwe njengezinhloso eziphambili zesigaba sesi-2 socwaningo. Inani eliqinile isisu amaseli ukuthi umthamo onconyiwe ungawabulala ngenkathi usasindisa amaseli anempilo.
Umdlavuza we-Colorectal, okuyigama lakho kokubili umdlavuza wekholomu kanye ne-rectal, kwenzeka lapho ama-polyps (amaqembu amaseli akhula ndawonye) akheka kukholoni noma ku-rectum bese ephenduka umdlavuza. Ukuguga, ukuba mnyama, ukuba nomlando wama-polyps noma umdlavuza emzimbeni wakho noma emndenini wakho, isifo samathumbu esivuthayo, izakhi zofuzo, isifo sikashukela, ukukhuluphala ngokweqile, ukudla okuvamile kwaseNtshonalanga, nokubhema nokuphuza yizo zonke izinto ezibeka abantu engozini.
Ukuhlinzwa, ngemisebe, ukwelashwa okuhlosiwe, kanye immunotherapy izindlela ezivame kakhulu zokwelapha umdlavuza we-colorectal. Nokho, izindlela eziningi zamanje zalo mdlavuza nezinye ezinamathumba aqinile zingabulala iziguli.
Ungahle uthande ukufunda: Izindleko zokwelashwa kwamaseli e-CAR T e-China
Abacwaningi abasebenze kulolu cwaningo bacabanga ukuthi lokhu Ukwelashwa kwe-CAR T-cell iphephile kunezinye izindlela zokwelapha ezihlosiwe. Lokhu kungenxa yokuthi CAR T-amaseli bulala amaseli wesimila ngaphandle kokulimaza amaseli anempilo ngoba aneswishi yokuphepha eyakhelwe ngaphakathi egcina izicubu ezinempilo zingalimali.
