RecruitingPhase 1NCT07078929

Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)

Safety and Preliminary Efficacy of CD19 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell (CMD63) in Relapse and Refractory Pediatric B-cell Acute Lymphoblastic Leukemia


Sponsor

Chulalongkorn University

Enrollment

16 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase 1 clinical trial to evaluate the safety and early efficacy of Chimeric Antigen Receptor T-cell (CAR T-cell) with IL-7Rα signaling targeting CD19 in children with relapsed and refractory B-cell Acute Lymphoblastic Leukemia (ALL) after complete standard treatments.


Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special type of immune cell therapy called CAR T-cell therapy (using a product called CMD63) for children with a type of blood cancer called acute lymphoblastic leukemia (ALL) that has come back or stopped responding to treatment. The therapy involves taking immune cells from the patient, engineering them to attack the cancer, and infusing them back. **You may be eligible if...** - You are between 1 and 18 years old - You have ALL that has relapsed or did not respond to at least one prior treatment - Your cancer cells have a marker called CD19 - Your heart, liver, kidneys, and lungs are working adequately - Your parents or guardians (or you, if old enough) can give informed consent **You may NOT be eligible if...** - You have active graft-versus-host disease (a complication from a prior transplant) - You have another active cancer - You have an uncontrolled infection, heart failure, or severe psychiatric condition - You are pregnant or breastfeeding - You have HIV, active hepatitis B, or active hepatitis C 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.

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Interventions

BIOLOGICALCD19-IL7Ra CAR-T cells

Autologous T cells lentiviral transduced to express a CD19-specific chimeric antigen receptor (CAR) with the addition of an IL-7 receptor alpha signaling domain, administered via central venous access catheter after lymphodepletion


Locations(3)

Siriraj Hospital

Bangkok, Bangkoknoi, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Mueang Chiang Mai District, Thailand

King Chulalongkorn Memorial Hospital

Bangkok, Pathumwan, Thailand

View Full Details on ClinicalTrials.gov

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NCT07078929


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