About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years old.
Karnofsky performance status score ≥ 70%.
Relapsed or refractory AML based upon ELN 2022 criteria.
Creatinine clearance: ≥ 40 mL/min (Cockroft-Gault).
Disqualifiers
Concomitant systemic glucocorticoid use at a dose equivalent to > 10 mg daily prednisone at the time of apheresis and/or within 4 weeks of CD83 CAR T infusion for any reasons other than GVHD.
Diagnosis of acute promyelocytic leukemia (APL; AML M3 by French-American-British [FAB] classification).
Active central nervous system (CNS) leukemia; patients with history of CNS leukemia in complete response (CR) are eligible.
Patients enrolled in another investigational therapy protocol for their disease within 14 days or 5 half-lives prior to leukapheresis, whichever is shorter.
Trial design
Treatments tested in this trial
- Autologous Anti-CD83 CAR T-cells
- Biospecimen Collection
- Chest Radiography
- Computed Tomography
- Cyclophosphamide
- Echocardiography
- Fludarabine Phosphate
- Hydroxyurea
- Leukapheresis
- Lumbar Puncture
- Positron Emission Tomography
- Questionnaire Administration
Treatment groups
Sponsors and collaborators
Roswell Park Cancer Institute
Lead sponsor
United States Department of Defense
Collaborator