45
Participants
Start Date
April 1, 2025
Primary Completion Date
April 30, 2027
Study Completion Date
April 30, 2029
CD33/CD123/CLL-1 CAR-T Cells
"Part A: Dose Escalation Phase. Follows a 3+3 dose escalation design with four predefined dose cohorts: 0.2×10⁶, 0.5×10⁶, 1×10⁶, and 2×10⁶ CAR-positive cells/kg.Anticipated enrollment: 12-24 subjects.Primary objectives: Assess safety, tolerability, and determine MTD.Dose-limiting toxicity (DLT) observation period: 28 days post-infusion.~Part B: Dose Expansion Phase.Enrolls 21 additional subjects to receive CAR-T cell infusion at the recommended Phase 2 dose (RP2D) established in Part A.Primary objective: Further evaluate therapeutic efficacy."
Tongji Hospital affiliated to Tongji Medical College of Huazhong University, Wuhan
Hebei Taihe Chunyu Biotechnology Co., Ltd
INDUSTRY
Tongji Hospital
OTHER