Exploratory Clinical Study on the Safety and Efficacy of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Myeloid Malignancies

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2029

Conditions
Myeloid MalignanciesCAR-T
Interventions
DRUG

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."

Trial Locations (1)

430030

Tongji Hospital affiliated to Tongji Medical College of Huazhong University, Wuhan

All Listed Sponsors
collaborator

Hebei Taihe Chunyu Biotechnology Co., Ltd

INDUSTRY

lead

Tongji Hospital

OTHER

NCT06917105 - Exploratory Clinical Study on the Safety and Efficacy of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Myeloid Malignancies | Biotech Hunter | Biotech Hunter