drugset / Trial / NCT06871410

Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

NCT06871410

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial tests the safety, side effects, and best dose of genetically engineered cells (CD83 chimeric antigen receptor \[CAR\] T cells) in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). CD83 is a protein that is found on AML blasts. Blasts are abnormal immature white blood cells that can multiply uncontrollably: filling up the bone marrow and preventing the production of other cells important for survival. CD83 CAR T cells represent a new cell therapy to eliminate AML blasts, while avoiding the risk for graft versus host disease (GVHD) after stem cell transplant to replace bone marrow or, tumor toxicity like myeloid aplasia where the body's own immune system causes damage to the bone marrow stem cells. Therefore, human CD83 CAR T cells are a promising cell-based approach to preventing two critical complications of stem-cell transplant - GVHD and relapse. Giving CD83 CAR T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory AML.

Timeline

Start
2026-03-02
Primary completion
2028-04-01
Completion
2028-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous Anti-CD83 CAR T-cells Cell therapy Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous
Background Hydroxyurea Other / unclassified