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

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).