drugset / Trial / NCT06642025
EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This is a early Phase 1 open-label, single-arm clinical study of EX02 CAR-T therapy for relapsed and refractory acute myeloid leukemia. Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy of cyclophosphamide and fludarabine, and an an intravenous infusion of CAR-T cells. Each participant will proceed through the following study procedures: * Screening * Enrollment/Leukapheresis * Conditioning chemotherapy * CAR T treatment * Post-treatment assessment * Long-term follow-up
Timeline
- Start
- 2024-09-01
- Primary completion
- 2026-08-01
- Completion
- 2029-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EX02 CAR-T | Cell therapy | 1e+06 cells/kg | Intravenous |
| Background | Acetaminophen | Small molecule | 500 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 250 mg/m2 | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |
| Background | Promethazine | Small molecule | 20 mg | Intramuscular |