NCT06871410

CD83 CAR T in Relapsed or Refractory Acute Myeloid Leukemia (AML): A Phase I Trial

Study 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.

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Interventions

Autologous Anti-CD83 CAR T-cellsDRUG
Given IV
Biospecimen CollectionPROCEDURE
Undergo bone marrow aspiration blood sample collection
Chest RadiographyPROCEDURE
Undergo chest x-ray
Computed TomographyPROCEDURE
Undergo CT
CyclophosphamideDRUG
Given IV
EchocardiographyPROCEDURE
Undergo ECHO
Fludarabine PhosphateDRUG
Given IV
HydroxyureaDRUG
Given hydroxyurea
LeukapheresisPROCEDURE
Undergo leukapheresis
Lumbar PuncturePROCEDURE
Undergo lumbar puncture
Positron Emission TomographyPROCEDURE
Undergo PET
Questionnaire AdministrationOTHER
Ancillary studies

Study Locations

FacilityCityStateCountry
Roswell Park Cancer InstituteBuffaloNew YorkUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026