CAR T Cell Therapy for Children, Teens, and Young Adults with CD19-Positive Leukemia

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60

ClinicalTrials ID:NCT06847269

Provider View

This study is testing a new treatment using CAR T cells, a type of therapy that uses modified immune cells to target leukemia cells in young patients whose cancer has returned or not responded to other treatments.

Patient Parameters

Program Overview

The CAR19PK study is exploring a new treatment for leukemia in children, teens, and young adults. This treatment involves using a patient's own immune cells, which are collected and modified in a lab to recognize and attack leukemia cells. The study aims to find out how effective this treatment is, how long the modified cells stay in the body, and what side effects might occur. It also looks at how the body processes the chemotherapy drugs used before the CAR T cell therapy.

Description

The CAR19PK study is a Phase II trial for children and young adults up to 21 years old with CD19-positive leukemia that has returned or not responded to treatment. The treatment involves a single round of chemotherapy to prepare the body, followed by an infusion of modified immune cells called CD19-CAR T cells. These cells are designed to target and destroy leukemia cells. The chemotherapy includes drugs called fludarabine and cyclophosphamide, with doses adjusted based on age. Participants will go through a two-step consent process: first, to agree to the collection of their immune cells, and second, to agree to the chemotherapy and CAR T cell infusion.

Eligibility Criteria

Inclusion Criteria

  • Have CD19-positive leukemia that is either:
    • Not responding to treatment
    • In its second or later relapse
    • Relapsed after a stem cell transplant
    • In first relapse but unable to have a stem cell transplant
  • Must confirm CD19 positivity within 3 months before joining the study
  • Be 21 years old or younger
  • Have a performance score of 50 or higher, indicating the ability to carry out daily activities
  • Have a life expectancy of more than 12 weeks
  • If previously had a stem cell transplant, must be recovered and not have active graft-versus-host disease
  • Females of childbearing age must not be pregnant or breastfeeding and must have a negative pregnancy test before joining

Exclusion Criteria

  • Have a known primary immune deficiency
  • Have a history of HIV infection
  • Have severe, uncontrolled infections
  • Have had allergic reactions to products containing mouse proteins
  • Have conditions that prevent receiving the chemotherapy used in the study
  • Have active disease in the central nervous system
  • Have uncontrolled neurological disease
  • Have severe, uncontrolled infections
  • Have conditions that prevent receiving the chemotherapy used in the study
  • Females of childbearing age must not be pregnant or breastfeeding and must agree to use birth control if sexually active

Locations

FACILITYZIPCITYSTATE
St. Jude Children's Research Hospital38105MemphisTennessee

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