Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

July 10, 2024

Primary Completion Date

December 10, 2025

Study Completion Date

December 28, 2026

Conditions
AMLAcute Myeloid LeukemiaAML, Adult RecurrentAML, Adult
Interventions
BIOLOGICAL

CD123/CD33 CART

"The intervention in this clinical trial involves a novel approach using CD22/123-Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies.~Treatment Regimen:~Patients in the trial will undergo the following regimen:~Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy.~Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2.~CD33/123-Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD33/123-CAR T cells, over 10-20 minutes on day 0.~Additional Doses: Eligible patients responding well to the initial CD33/123 CAR-T cell infusion without unacceptable side effects and sufficient CAR T cell availability may receive 2 or 3 additional doses."

Trial Locations (1)

086-373

RECRUITING

District One Hospital, Beijing

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Essen Biotech

OTHER