Condition: T-Cell Acute Lymphocytic Leukemia · Acute Lymphoblastic Leukemia, in Relapse · Refractory Acute Lymphoblastic Leukemia · Sponsor: Beijing GoBroad Hospital
This is a multi-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\^6 (±20%) to dose level 2: 2×10\^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10\^5 (±20%) /kg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled.
This description comes directly from the study's public registry record.
Shaocong Miao · 86+18831006667 · miaosc@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, 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/NCT07070323