Study on Using a New Method to Make huCART19 T Cells for Treating Pediatric B-Cell Acute Lymphoblastic Leukemia

Sponsor: Stephan Grupp MD PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05480449

Provider View

This clinical trial is testing a new, faster, and safer way to produce huCART19 T cells for children and young adults with B-Cell Acute Lymphoblastic Leukemia (B-ALL) using the CliniMACS Prodigy platform.

Patient Parameters

Program Overview

The study aims to find out if a new method for making huCART19 T cells is safe and effective for treating children and young adults with B-Cell Acute Lymphoblastic Leukemia (B-ALL). The new method uses the CliniMACS Prodigy platform, which is faster and more automated than the older method, potentially reducing the waiting time for patients who need this treatment.

Description

CAR T-cell therapy is a promising treatment for children and young adults with B-Cell Acute Lymphoblastic Leukemia (B-ALL) that has come back or is hard to treat. However, the current way of making these cells is slow and requires a lot of work, which can be risky for patients who need treatment quickly. This study is testing a new method using the CliniMACS Prodigy platform, which is more automated and faster, to make huCART19 T cells. This new method could help get the treatment to patients more quickly and safely. The study will look at how safe and effective this new method is for making the cells.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed informed consent.
  • Have a confirmed diagnosis of CD19+ Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (Lly).
    • Cohort A: Patients with relapsed or hard-to-treat ALL or Lly.
    • Cohort B: Patients who did not respond well to previous B cell-targeted therapies.
  • Patients with a history of central nervous system (CNS) disease can participate if their CNS disease is responding to treatment.
  • Must show CD19 tumor expression in bone marrow, blood, spinal fluid, or tumor tissue.
  • Ages 0 to 29 years.
  • Must have adequate organ function.
  • Must have a performance status score of 50 or higher.
  • Patients who can have children must agree to use birth control.

Exclusion Criteria

  • Have active hepatitis B or C.
  • Have HIV infection.
  • Have active graft-versus-host disease (GVHD) needing treatment.
  • Are using systemic steroids or immunosuppressants at the time of cell infusion or collection, or are likely to need them during or after treatment.
  • Have CNS disease that is getting worse or have brain lesions that could increase the risk of side effects.
  • Are pregnant or breastfeeding.
  • Have an uncontrolled active infection.
  • Have a history of seizures needing ongoing treatment.
  • Have had severe side effects from previous CAR T cell therapies.

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