Condition: B Cell Lymphoma · 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 Lymphoma. For simplicity, we have termed these CD19 CAR T cells lacking ZC3H12A and BCOR as CAR19TIF( immortal-like and functional CD19 CAR T ) cells, reflecting their immortal-like and functional characteristics. In phase 1, 3 eligible patients will be enrolled and receive CAR19TIF cells 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 CAR19TIF 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 CAR19TIF cells 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.
| Biotherapeutic Department of Chinsese PLA Gereral Hospital | Beijing, Beijing Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07009002