RecruitingNot ApplicableNCT06866873

CD-19 CAR-T Cell for Pediatric ALL or Lymphoma

Safety and Feasibility Study of CD19 Chimeric Antigen Receptor (CAR) T Cells in Children with Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia or Lymphoma


Sponsor

Hong Kong Children's Hospital

Enrollment

18 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.


Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR T cell therapy — immune cells re-engineered to attack cancer — in children and young patients with relapsed or treatment-resistant ALL (a type of blood cancer) or lymphoma that expresses the CD19 protein. **You may be eligible if...** - You have relapsed or refractory ALL or lymphoma after at least two previous treatment regimens - Your cancer tests positive for the CD19 protein - You are in adequate overall health with functioning organs - You (or your guardian) are able to give informed consent **You may NOT be eligible if...** - Your cancer no longer expresses the CD19 protein - You have active, uncontrolled infection (including HIV or hepatitis) - You have had a prior CAR T cell therapy targeting CD19 - You have serious heart, lung, or kidney problems 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

BIOLOGICALCAR-T

CAR-T cell (CHXCART01) infusion intravenously once at a dose of 0.2-2 million cells/kg recipient body weight


Locations(1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

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NCT06866873


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