OncoMatch/Clinical Trials/NCT06871410
Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Is NCT06871410 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Autologous Anti-CD83 CAR T-cells and Cyclophosphamide for recurrent acute myeloid leukemia.
Treatment: Autologous Anti-CD83 CAR T-cells · Cyclophosphamide · Fludarabine Phosphate · Hydroxyurea — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Prior therapy
Cannot have received: investigational therapy
Patients enrolled in another investigational therapy protocol for their disease within 14 days or 5 half-lives prior to leukapheresis, whichever is shorter.
Cannot have received: solid organ transplant
Prior solid organ transplant.
Lab requirements
Blood counts
Absolute lymphocyte count: ≥ 0.2 x 10^9/L, HCT of ≥ 27% and platelets of ≥ 20 x 10^9/L. Transfusion support is allowed to meet HCT and platelet parameters prior to apheresis.
Kidney function
Creatinine clearance: ≥ 40 mL/min (Cockroft-Gault).
Liver function
Total bilirubin: ≤ 2mg/dL except for patients with Gilbert's syndrome, hemolysis, or related to disease. AST and ALT < 3.0 x ULN.
Cardiac function
Left ventricular (LV) ejection fraction: > 45% and be free of symptomatic congestive heart failure or uncontrolled arrhythmia.
Creatinine clearance: ≥ 40 mL/min (Cockroft-Gault). Total bilirubin: ≤ 2mg/dL except for patients with Gilbert's syndrome, hemolysis, or related to disease. AST and ALT < 3.0 x ULN. Left ventricular (LV) ejection fraction: > 45% and be free of symptomatic congestive heart failure or uncontrolled arrhythmia. Absolute lymphocyte count: ≥ 0.2 x 10^9/L, HCT of ≥ 27% and platelets of ≥ 20 x 10^9/L. Transfusion support is allowed to meet HCT and platelet parameters prior to apheresis.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Roswell Park Cancer Institute · Buffalo, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify