OncRef

Clinical Trial: NCT02146924

Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:City of Hope Medical Center
Information Provided By:City of Hope Medical Center
Last Update Posted:2026-08-05

Study Overview

Brief Summary

This phase I trial studies the side effects and best dose of cellular immunotherapy in treating patients with high-risk acute lymphoblastic leukemia. Placing a modified gene into white blood cells may help the body build an immune response to kill cancer cells.

Official Title

Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients With High-Risk CD19+ Acute Lymphoblastic Leukemia

Conditions

B Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia

Intervention / Treatment

  • Biological: CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes
  • Biological: CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes
  • Other: Laboratory Biomarker Analysis

Other Study ID Numbers

  • 13447
  • NCI-2014-01060
  • 120202
  • 111660
  • 109630
  • 113660
  • 13447/115692
  • 118097
  • 13447

Start Date (Actual)

2014-10-16

Primary Completion Date (Estimated)

2027-06-17

Study Completion Date (Estimated)

2027-06-17

Enrollment (Actual)

71

Study Type

Interventional

Phase

Phase 1