A Phase I Study of UCART22 CAR T-Cell Therapy in Children and Young Adults with Recurrent or Persistent B-Cell Acute Lymphoblastic Leukemia

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Full Title

Open Label Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-Cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients with Relapsed or Refractory CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Purpose

The purpose of this study is to find the highest dose of the investigational treatment UCART22 that can be given safely in children and young adults with B-cell acute lymphoblastic leukemia (ALL) that has come back or continued to grow despite treatment. UCART22 is a form of CAR T-cell therapy. It is made from white blood cells (T cells) from healthy donors. The T cells are genetically modified in a laboratory to identify and destroy cancer cells containing a protein called CD22.

Before receiving UCART22, patients will receive “conditioning” chemotherapy (fludarabine, cyclophosphamide, and alemtuzumab) to remove immune cells that could prevent UCART22 from working effectively. The treatments in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have B-cell ALL that came back or continued to grow despite treatment.
  • Patients’ cancer cells must have CD22 on their surfaces.
  • The serious side effects of previous treatments must go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 15-25.

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

Protocol

21-488

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators