{"entity":{"id":"inaticabtagene-autoleucel","kind":"drug","name":"Inaticabtagene autoleucel","aka":[],"tldr":"Inati-cel is a Chinese CAR-T for adults with acute lymphoblastic leukaemia that has come back or stopped responding, approved in 2023.","summary":"Developed by Juventas Cell Therapy with the Institute of Hematology and Blood Diseases Hospital of the Chinese Academy of Medical Sciences, and approved by the NMPA in 2023 for adult relapsed or refractory CD19-positive B-cell acute lymphoblastic leukaemia, the first CAR-T approved in China for leukaemia. It illustrates how China's academic haematology centres have become the origin of approved cell therapies rather than only trial sites.","status":"approved","asOf":"2026-09-10","links":[{"label":"Juventas Cell Therapy","url":"https://www.juventas.cn/"},{"label":"NMPA (National Medical Products Administration)","url":"https://www.nmpa.gov.cn"}],"tags":["china"],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":[],"companies":["juventas-cell-therapy"],"institutions":["cams-hematology"],"pathways":[],"terms":[],"trials":["nct05667506","nct04684147","nct04586478"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Yuanruida","code":"inati-cel, CNCT19","modality":"Cell therapy (autologous CD19 CAR-T)","mechanism":"Autologous CD19-directed CAR-T cells using a novel CD19 binder (HI19a) developed at the Institute of Hematology, Chinese Academy of Medical Sciences, in Tianjin.","approvals":[{"region":"China","year":2023,"indication":"Adult relapsed or refractory CD19-positive B-cell acute lymphoblastic leukaemia"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/inaticabtagene-autoleucel/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"}],"company":[{"id":"juventas-cell-therapy","kind":"company","name":"Juventas Cell Therapy","route":"/companies/juventas-cell-therapy/"}],"institution":[{"id":"cams-hematology","kind":"institution","name":"Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences","route":"/institutions/cams-hematology/"}],"trial":[{"id":"nct05667506","kind":"trial","name":"A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)","route":"/trials/nct05667506/"},{"id":"nct04684147","kind":"trial","name":"Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia","route":"/trials/nct04684147/"},{"id":"nct04586478","kind":"trial","name":"Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma","route":"/trials/nct04586478/"}]}}