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Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Sponsor: Roswell Park Cancer Institute
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.
Official title: CD83 CAR T in Relapsed or Refractory Acute Myeloid Leukemia (AML): A Phase I Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2026-03-02
Completion Date
2028-04-01
Last Updated
2026-03-24
Healthy Volunteers
No
Interventions
Autologous Anti-CD83 CAR T-cells
Given IV
Biospecimen Collection
Undergo bone marrow aspiration blood sample collection
Chest Radiography
Undergo chest x-ray
Computed Tomography
Undergo CT
Cyclophosphamide
Given IV
Echocardiography
Undergo ECHO
Fludarabine Phosphate
Given IV
Hydroxyurea
Given hydroxyurea
Leukapheresis
Undergo leukapheresis
Lumbar Puncture
Undergo lumbar puncture
Positron Emission Tomography
Undergo PET
Questionnaire Administration
Ancillary studies
Locations (1)
Roswell Park Cancer Institute
Buffalo, New York, United States