CD22 CAR T-Cell Therapy to Prolong Remission After CD19 CAR T-Cell Treatment in Children, Teens, and Adults with Relapsed or Hard-to-Treat B-cell Acute Lymphoblastic Leukemia

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT07328503

Provider View

This study is exploring whether a second CAR T-cell therapy, targeting a different marker called CD22, can help keep leukemia from returning in patients who have already received CD19 CAR T-cell therapy.

Patient Parameters

Program Overview

Acute lymphoblastic leukemia (ALL) is a type of blood cancer. CAR T-cell therapy uses a person's own immune cells, modified to better attack cancer cells. While CD19 CAR T-cell therapy can cure many cases of ALL, the cancer often returns in about half of the patients within a year. This study aims to see if using a second CAR T-cell therapy that targets CD22 can help keep the cancer away for longer.

Description

This study focuses on patients with B-cell acute lymphoblastic leukemia (B-ALL) that is difficult to treat or has returned after treatment. While CD19 CAR T-cells have been effective in inducing remission, the cancer often comes back without a stem cell transplant, which can have serious side effects. By targeting both CD19 and CD22 markers, researchers hope to improve the long-term success of CAR T-cell therapy. Previous studies have shown promising results when using both CD19 and CD22 CAR T-cells together. This study will test the effectiveness and safety of CD22 CAR T-cells in extending remission after CD19 CAR T-cell therapy. Participants will receive a preparatory treatment to ready their body for the CD22 CAR T-cells, followed by the infusion of these modified cells. They will be monitored for two years to evaluate the treatment's effects and any side effects. The study aims to enroll up to 20 participants to ensure enough data is collected.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia (ALL).
  • History of CD19 and CD22 markers on cancer cells.
  • Aged between 3 and 65 years.
  • Received CD19 CAR T-cell therapy 2 to 7 months before starting this study.
  • Currently in remission with no detectable cancer cells.
  • Not eligible for or unwilling to have a stem cell transplant.
  • Good overall health with a performance status score of at least 50%.
  • No ongoing side effects from previous CAR T-cell therapy.
  • Adequate organ function, including liver, kidney, heart, and lung health.
  • Women of childbearing age must use effective birth control during and after the study.
  • Men must use effective birth control during and after the study.
  • Willing to stop breastfeeding during and after the study.
  • Enrolled in a related follow-up study for gene therapy side effects.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Cancer has spread to the brain or other areas outside the bone marrow.
  • Active graft versus host disease after a stem cell transplant.
  • Cancer has returned and needs treatment after CD19 CAR T-cell therapy.
  • Received any experimental treatment within a week before starting this study.
  • Pregnant or breastfeeding.
  • Positive for HIV, hepatitis B, or hepatitis C.
  • Severe allergic reactions to similar treatments.
  • Other serious health issues that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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