Study on UCD19 CAR-T Therapy for Treating Pediatric B-ALL and B-NHL

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04544592

Provider View

This clinical trial is testing a new CD19 CAR-T cell therapy, made locally, to help children and young adults with B-cell Non-Hodgkin Lymphoma (B-NHL) and B-cell Acute Lymphoblastic Leukemia (B-ALL) who have not responded to other treatments or have relapsed.

Patient Parameters

Program Overview

The aim of this study is to explore a new CD19 CAR-T cell therapy that is produced locally, allowing for quicker treatment and including more patients, such as children with B-cell Non-Hodgkin Lymphoma (B-NHL) and those who have relapsed. This therapy is designed to be safe and effective for young patients with difficult-to-treat B-ALL or B-NHL.

Description

Children and young adults with leukemia or lymphoma that doesn't respond to standard treatments often have poor outcomes. CAR-T cell therapy has shown promise for these conditions, but not all patients qualify for it, and the wait for commercially available treatments can be long. This study is testing a new CD19 CAR-T therapy, made locally, to include more patients and reduce waiting times. The therapy uses the Prodigy ClinicMACS system to create CAR-T cells that target CD19, a marker on cancer cells. The study aims to show that this treatment is safe and effective for children and young adults with relapsed or hard-to-treat B-ALL or B-NHL.

Eligibility Criteria

Inclusion Criteria

  • Eligible for blood cell collection or have stored blood cells ready for use.
  • Signed consent from a parent or guardian for those under 18, or from the patient or their representative if over 18.
  • Willing to participate in long-term follow-up.
  • Agree to follow all study procedures and be available for the study duration.
  • Male or non-pregnant, non-breastfeeding females.
  • Aged between 31 days and 30 years.
  • Diagnosed with B-cell Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkin Lymphoma (NHL) that:
    • Shows CD19 marker.
    • Has relapsed multiple times, after bone marrow transplant, or is resistant to standard treatments.
    • Includes specific types of NHL like Diffuse Large B-cell Lymphoma, Burkitt Lymphoma, and others.
  • Performance score of 50% or better.
  • Cannot receive commercially available CD19 CAR-T therapy.

Exclusion Criteria

  • Active, uncontrolled leukemia or lymphoma in the central nervous system.
  • Active Graft-versus-Host Disease (GvHD).
  • Active, uncontrolled, life-threatening infection that prevents safe treatment.
  • Severe organ dysfunction that prevents safe treatment, including:
    • Heart problems.
    • Low oxygen levels.
    • Poor lung function.
    • High liver enzymes or bilirubin levels.
    • Poor kidney function.
  • Post-pubertal females who are pregnant, planning to become pregnant, or not using birth control.
  • Known HIV, active Hepatitis B, or active Hepatitis C infection.
  • Previous gene therapy, including CAR-T cell therapy.

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