Condition: T-cell Acute Lymphoblastic Leukemia · Acute Lymphoblastic Leukemia, in Relapse · Refractory Acute Lymphoblastic Leukemia · Sponsor: Beijing GoBroad Hospital
This is a multi-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell malignancies will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled.
This description comes directly from the study's public registry record.
zhuojun ling · 86+18611422920 · lingzj@gobroadhealthcare.com
Always discuss trial participation with your own doctor first.
| Beijing GoBroad Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine | Shanghai, Shanghai Municipality, China | Recruiting |
| Shanghai Liquan Hospital | Shanghai, Shanghai Municipality, China | Recruiting |
| The General Hospital of Western Theater Command PLA | Chengdu, Sichuan, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06316427