Roswell Park Cancer Institute
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.
PRIMARY OBJECTIVE: I. To evaluate the safety and determine the maximal tolerated dose (MTD) of autologous anti-CD83 CAR T-cells (CD83 CAR T cells) administered as a single infusion to refractory/relapsed acute myeloid leukemia (AML) patients. SECONDARY OBJECTIVES: I. To observe and record activity against AML. II. To evaluate response for AML using 2022 European Leukemia Net (ELN) criteria. III. To evaluate progression-free and overall survival after CAR T cell infusion. IV. To evaluate the time to hematological recovery after CAR T cell infusion. V. To evaluate in vivo CAR T cell expansi…
Inclusion Criteria: * 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). * Total bilirubin: ≤ 2mg/dL except for patients with Gilbert's syndrome, hemolysis, or related to disease. * Aspartate aminotransferase (AST) and alanine transaminase (ALT) \< 3.0 x upper limit of normal (ULN). * Left ventricular (LV) ejection fraction: \> 45% and be free of symptomatic congestive heart failure or uncontrolled arrhythmia. * Oxygen (O2) saturation: ≥ 92% on room air without needs f…
Given IV
Undergo bone marrow aspiration blood sample collection
Undergo chest x-ray
Undergo CT
Given IV
Undergo ECHO
Given IV
Given hydroxyurea
Undergo leukapheresis
Undergo lumbar puncture
Undergo PET
Ancillary studies
Arctuva estimate
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