drugset / Trial / NCT05707273

CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission

NCT05707273 ↗

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial tests the safety, side effects, and best dose of autologous anti-CD19 CAR-expressing T lymphocytes (CD19-CAR T cells) in older adults with B-cell acute lymphoblastic leukemia. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of B-cell acute lymphoblastic leukemia.

Timeline

Start
2023-04-26
Primary completion
2026-07-24
Completion
2026-07-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous Anti-CD19 CAR-expressing T Lymphocytes Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous