A Phase I Study of JCAR017 in Children with B-Cell Acute Lymphoblastic Leukemia

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Full Title

A Phase 1/2, Open-Label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects with Relapsed/Refractory B-ALL and B-NHL (TRANSCEND PEDALL)

Purpose

The purpose of this study is to evaluate the safety and effectiveness of a novel treatment for children with B-cell acute lymphoblastic leukemia (ALL) that has continued to grow or came back despite prior therapy. The treatment involves removing some of a patient’s immune cells called T cells, genetically modifying and growing them in a laboratory, and then returning them to the patient to find and kill lymphoma cells. 

The newly modified T cells are called JCAR017 cells and are given back to the patient intravenously (by vein). This approach is a form of immunotherapy. Its use in children with B-cell ALL is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have B-cell ALL that has come back or continued to grow despite treatment.
  • Patients’ cancers must be positive for the CD19 protein (the target of JCAR017).
  • Patients should recover from the serious side effects of prior treatments before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients under age 18 years.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

21-240

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators