RecruitingEarly Phase 1NCT06642025

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

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


Sponsor

Zhimin Zhai

Enrollment

9 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of CAR-T cell therapy (called EX02 CAR-T) for people with acute myeloid leukemia (AML) that has come back or has not responded to standard chemotherapy. CAR-T therapy involves modifying a patient's own immune cells to target and attack leukemia cells. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with AML that has relapsed or has not responded to standard treatment - Your leukemia cells test positive for the EX02 target protein - Your blood counts and organ function are within acceptable ranges - Your general health status is adequate (ECOG 0-2) **You may NOT be eligible if...** - You have active hepatitis A, B, C, or HIV - You have significant heart problems (heart failure, recent heart attack, or dangerous arrhythmias) - You are pregnant or breastfeeding - You have severe liver or kidney dysfunction - You have had a stem cell transplant and have not been off immunosuppressants for at least 6 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCAR-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06642025


Related Trials