OncRef

Clinical Trial: NCT01044069

Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Memorial Sloan Kettering Cancer Center
Information Provided By:Memorial Sloan Kettering Cancer Center
Last Update Posted:2026-09-08

Study Overview

Brief Summary

This study is an investigational approach that uses immune cells, called "T cells", to kill leukemia. These T cells are removed from blood, modified in a laboratory, and then put back in the body. T cells fight infections and can also kill cancer cells in some cases. However, right now T cells are unable to kill the cancer cells. For this reason we will put one gene into the T cells that allows them to recognize and kill the leukemia cells. This gene will be put in the T cells by a weakened virus. The gene will produce proteins in the T cells that help the T cells recognize the leukemia cells and possibly kill them. The doctors have found that T cells modified in this way can cure an ALL-like cancer in mice.

The main goals of this study is to determine the safety and appropriate dose of these modified T cells in patients with ALL. This will be done in a "clinical trial." The dose of modified T-cells will depend on if you have disease present in your bone marrow or not. The patient will also receive chemotherapy before the T cells. We will use normally chemotherapy that is used in patients with leukemia. The chemotherapy is given to reduce leukemia and to allow the T cells to live longer.

Official Title

A Phase I Trial of Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19

Conditions

Leukemia, Acute Lymphoblastic Leukemia

Intervention / Treatment

  • Biological: gene-modified T cells targeted

Other Study ID Numbers

  • 09-114

Start Date (Actual)

2010-01-05

Primary Completion Date (Estimated)

2027-01

Study Completion Date (Estimated)

2027-01

Enrollment (Estimated)

93

Study Type

Interventional

Phase

Phase 1