Study on Genetically Modified T Cells Targeting CD22 for Children and Young Adults with Difficult-to-Treat Leukemia or Lymphoma

Sponsor: Seattle Children's Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04571138

Provider View

This clinical trial is exploring a new treatment using genetically modified T cells to target a protein called CD22 on leukemia and lymphoma cells in children and young adults whose cancer has returned or not responded to treatment.

Patient Parameters

Program Overview

This study is testing a new approach to treat leukemia and lymphoma in children and young adults whose cancer has come back or not responded to other treatments. The treatment involves using the patient's own T cells, which are a type of white blood cell, and modifying them in the lab to recognize and attack cancer cells with a protein called CD22. The first part of the study will focus on finding a safe dose, while the second part will evaluate how well the treatment works. Both patients who have and have not received similar treatments before may be eligible to participate.

Eligibility Criteria

Inclusion Criteria

  • Boys and girls up to 30 years old. The first two participants must be between 18 and 30 years old.
  • Have leukemia or lymphoma that has returned or not responded to treatment and shows the CD22 protein.
  • Able to undergo a procedure to collect T cells or have enough T cells already collected for the treatment.
  • Expected to live at least 8 more weeks.
  • Have a performance score of 50 or higher, indicating the ability to carry out daily activities.
  • Recovered from any immediate side effects of previous cancer treatments.
  • At least 7 days since the last chemotherapy or biological therapy, except for certain maintenance treatments.
  • At least 7 days since the last steroid treatment.
  • At least 3 days since the last use of Tyrosine Kinase Inhibitors (TKIs).
  • At least 1 day since the last use of hydroxyurea.
  • At least 30 days since the last CAR T cell therapy.
  • Have good organ function and adequate blood test results, including a lymphocyte count of at least 100 cells/uL.
  • Agree to use effective birth control during the study and for 12 months after the treatment.
  • Willing to sign a consent form to participate in the study.

Exclusion Criteria

  • Have another active cancer besides the one being studied.
  • Have a history of or current symptoms of central nervous system (CNS) issues.
  • Have leukemia or lymphoma in the CNS that cannot be controlled before the treatment.
  • Have not tried CD19 CAR T cell therapy if their cancer cells show the CD19 protein.
  • Have had a stem cell transplant and have active graft-versus-host disease (GVHD) or are on medication for GVHD within 4 weeks before joining the study.
  • Have a severe active infection.
  • Have a primary immunodeficiency disorder.
  • Have received virus-based therapy before.
  • Are pregnant or breastfeeding.
  • Do not agree to participate in a 15-year follow-up if they receive the CAR T cell therapy.
  • Have any condition that the study doctor believes would prevent them from safely participating in the study.

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