OncoMatch/Clinical Trials/NCT06731504
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Is NCT06731504 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Abatacept for hematologic malignancy.
Treatment: Abatacept — This study is a single-center, non-randomized, single-arm pilot trial of omidubicel hematopoietic stem cell transplantation (HCT) for hematologic malignancies with myeloablative conditioning chemotherapy of physician's choice followed by abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) graft-versus-host disease (GVHD) prophylaxis. The primary objective is to assess the safety and feasibility of abatacept/tacrolimus/mycophenolate mofetil GVHD prophylaxis following omidubicel HCT. Target enrollment is 10 participants. Subjects are adults with a diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing. Patients will be followed for a total of 18 months and will have research blood draws and Abatacept pharmacokinetics, as well as standard of care assessments that will be reviewed for this study. It is estimated that 36 months of accrual will be necessary to enroll the targeted sample size with an accrual rate of approximately 1 participant every 3 months. Accrual will be reported by race, ethnicity, gender, and age. Descriptive analyses are planned given the sample size.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Lab requirements
Kidney function
serum creatinine within normal range, or if serum creatinine outside normal range, must have measured or estimated creatinine clearance > 40 ml/min/1.73m2
Liver function
total bilirubin ≤ 2.5 mg/dl except for patients with gilbert's syndrome or hemolysis, and alt, ast, and alkaline phosphatase all < 5 x upper limit of normal (uln)
Cardiac function
left ventricular ejection fraction ≥ 40%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Duke University Health System · Durham, North Carolina
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