Condition: Acute Lymphocytic Leukemia · Sponsor: Chinese PLA General Hospital
In this single-center, single-arm, prospective, Phase 1/2 study, the safety and efficacy of autologous BCOR and ZC3H12 genes knock-out CD19-targeting chimeric antigen receptor (CAR) T-cell therapy will be evaluated in patients with refractory/relapsed (r/r) B-cell acute lymphoblastic leukaemia (B-ALL). In phase 1, 3 eligible patients will be enrolled and receive BCOR and ZC3H12 genes knock-out CD19 CAR T cell therapy at a initial dose of 5×10\^5 cells/kg. Based on the results, . Subsequently an additional 3-15 patients will be enrolled in a "3+3" dose-escalation/decline design to adjust the dose of BCOR and ZC3H12 genes knock-out CD19 CAR T cells to achieve optimal safety and efficacy. The recommended Phase 2 dose (RP2D) will then be established. 10 to 12 subjects will be enrolled and receive BCOR and ZC3H12 genes knock-out CD19 CAR T cell infusion at dose of RP2D.
This description comes directly from the study's public registry record.
Weidong Han, Ph.D · 010-66937231 · hanwdrsw@sina.com
Yang Liu, M.D · 010-66939460 · liuyang301blood@163.com
Always discuss trial participation with your own doctor first.
| China | Beijing, Biotherapeutic Department of Chinese PLA General Hospital, China | Recruiting |
| China | Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07008885