Study on CAR T Cells Targeting CD19 and CD22 in Children and Young Adults with Hard-to-Treat B Cell Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05442515

Provider View

This clinical trial is testing a new CAR T-cell therapy that targets two proteins, CD19 and CD22, to treat children and young adults with B cell cancers that have returned or not responded to standard treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment for children and young adults with certain B cell cancers, like acute lymphoblastic leukemia (ALL), that have come back or are not responding to usual treatments. The treatment uses a special type of cell therapy called CAR T-cell therapy, which is made from the patient's own blood cells and is designed to target two proteins, CD19 and CD22, found on cancer cells. The goal is to see if this approach is safe and effective in reducing cancer in patients aged 3 to 39 years.

Description

This clinical trial is testing a new CAR T-cell therapy that targets both CD19 and CD22 proteins on cancer cells. This approach aims to improve treatment for children and young adults with B cell cancers, like acute lymphoblastic leukemia (ALL), that have returned or are not responding to standard treatments.

The study is divided into two phases. Phase I focuses on determining the safety of the treatment by gradually increasing the dose of the CAR T-cells. Phase II evaluates how well the treatment works in reducing cancer. Participants will receive chemotherapy before the CAR T-cell therapy to prepare their bodies.

Participants will undergo several tests, including blood tests, imaging scans, and bone marrow biopsies, to ensure they meet the study criteria. They will also have a procedure called apheresis, where blood is drawn, and T cells are collected and modified in a lab to better fight cancer. These modified T cells are then infused back into the participant's body.

After the treatment, participants will be closely monitored for side effects and to assess how well the cancer responds. Follow-up visits will continue for up to 15 years to track long-term outcomes and any delayed side effects.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of B cell ALL or related high-grade lymphoma that has returned or not responded to standard treatments.
  • Must be between 3 and 39 years old.
  • Must have cancer cells that express CD19 and CD22 proteins.
  • Must have adequate organ function and meet specific blood count levels.
  • Must not have active graft-versus-host disease if they had a previous stem cell transplant.
  • Must be willing to use effective birth control during and after the study.
  • Must be able to understand and sign a consent form or have a legal representative do so.

Exclusion Criteria

  • Cannot have active disease in the central nervous system (CNS) or certain neurological conditions.
  • Cannot have very high white blood cell counts.
  • Cannot be pregnant or breastfeeding.
  • Must meet specific time requirements since last receiving certain cancer treatments.
  • Cannot have active infections like HIV or hepatitis B or C.
  • Cannot have another active cancer unless treated and in remission for at least two years.
  • Cannot have severe allergies to study drugs or components.
  • Cannot have uncontrolled illnesses or social situations that would interfere with the study.

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