Study on Using Two CAR T Cell Therapies, CART22-65s and huCART19, for Treating Advanced B Cell Acute Lymphoblastic Leukemia (B-ALL)

Sponsor: Stephan Grupp MD PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05674175

Provider View

This clinical trial is testing the safety and effectiveness of two CAR T cell therapies, huCART19 and CART22-65s, in children and young adults with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).

Patient Parameters

Program Overview

The study aims to find out if using two CAR T cell therapies together—huCART19 and CART22-65s—can help treat children and young adults with advanced B cell Acute Lymphoblastic Leukemia (B-ALL). These therapies are designed to target specific proteins on cancer cells and help the immune system fight the cancer more effectively.

Description

CAR T cell therapy has been a breakthrough for treating children and young adults with B cell Acute Lymphoblastic Leukemia (B-ALL) that doesn't respond to chemotherapy or comes back after treatment. However, about half of the patients experience a return of the disease after initial treatment with CAR T cells targeting CD19. This study is testing a new approach by using two different CAR T cell therapies together. One therapy, CART22-65s, targets a protein called CD22 to help overcome the cancer's ability to escape treatment. The other therapy, huCART19, is a humanized version that aims to prevent the immune system from rejecting the treatment. The goal is to improve the chances of long-term remission for patients who have relapsed or have not responded well to previous treatments.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed informed consent.
  • Have a diagnosis of B cell Acute Lymphoblastic Leukemia (B-ALL) with CD19+ and/or CD22+ markers.
    • Group A: Patients whose cancer has returned or not responded to treatment.
    • Group B: Patients who did not respond well to previous B cell targeted therapies.
  • Patients with a history of Central Nervous System disease can participate if the disease is responding to treatment.
  • Must show CD19 and/or CD22 markers in bone marrow, blood, spinal fluid, or tumor tissue.
  • Age between 0 and 29 years.
  • Must have good organ function.
  • Must have a performance status score of 50 or higher.
  • Must agree to use effective birth control if of reproductive age.

Exclusion Criteria

  • Have active hepatitis B or C.
  • Have HIV infection.
  • Have active Graft Vs. Host Disease requiring treatment.
  • Cannot be using systemic steroids or immunosuppressive drugs at the time of cell therapy.
  • Cannot have progressive Central Nervous System disease or lesions that increase the risk of brain-related side effects.
  • Cannot be pregnant or breastfeeding.
  • Cannot have uncontrolled active infections.

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