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RECRUITING
NCT06642025
EARLY_PHASE1

EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia

Sponsor: Zhimin Zhai

View on ClinicalTrials.gov

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

Official title: An Open-label, Single-arm Clinical Study of EX02 CAR-T Therapy for Relapsed and Refractory Acute Myeloid Leukemia

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2024-09-01

Completion Date

2029-09-01

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

CAR-T Cell Injection

Conditioning chemotherapy: Lymphodepletion regimen consisting of fludarabine 25 mg/m2/day and cyclophosphamide 250 mg/m2/day for 3 consecutive days, administered 48 hours before intraperitoneal infusion. On the day of administration, premedication with 500mg of acetaminophen orally and 20mg of promethazine intramuscularly or intravenously (or other non-steroidal anti-inflammatory drugs and antihistamines) should be given 30 minutes before intraperitoneal infusion. The therapeutic dose of CAR-T cells is defined as intravenous injection of 1.0E6 CAR-T cells/kg as the initial standard dosage.

Locations (1)

The Second Affliated Hospital of Anhui Medical University

Hefei, Anhui, China