Actively Recruiting
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Led by Duke University · Updated on 2026-01-16
10
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hematologic malignancy with an available cord blood unit for omidubicel manufacturing
- Adults aged 18 years or older at enrollment
- Adequate organ function as defined by: left ventricular ejection fraction ≥ 40%; lung function (DLCO, FEV1, FVC) > 50% predicted; total bilirubin ≤ 2.5 mg/dL (exceptions for Gilbert's syndrome or hemolysis); ALT, AST, alkaline phosphatase < 5 times upper limit of normal; normal serum creatinine or creatinine clearance > 40 mL/min/1.73m2
- Karnofsky performance score of 70 or higher
- If applicable, more than 6 months since prior autologous transplant
- Female patients (unless postmenopausal or surgically sterilized) and all male patients must agree to use two effective contraception methods simultaneously or abstain from heterosexual intercourse from consent through 100 days post-transplant
You will not qualify if you...
- Known sensitivity to dimethyl sulfoxide, dextran 40, gentamicin, human serum albumin, or bovine material
- Presence of donor-specific antibodies with mean fluorescence intensity greater than 2000
- Uncontrolled bacterial, fungal, or viral infection
- Treatment with other investigational medical products without FDA-approved indications without prior discussion with the principal investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Duke University Health System
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
S
Sanghee Hong, MD
CONTACT
L
Lauren Hill
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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