NCT06731504 HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
| NCT ID | NCT06731504 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Duke University |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-11-12 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. A diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing 2. Adult patients (≥18 at the time of enrollment) 3. Adequate organ function for transplant defined as: 1. Left ventricular ejection fraction ≥ 40%; 2. DLCO, FEV1, FVC \> 50% predicted; 3. 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); 4. Serum creatinine within normal range, or if serum creatinine outside normal range, must have measured or estimated creatinine clearance \> 40 mL/min/1.73m2; 5. Karnofsky performance score ≥ 70; and 6. If applicable, \> 6 months since a previous autologous transplant. 4. Female patients (unless postmenopausal or surgically sterilized) and male patients (even if surgically sterilized) must agree to practice two effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse from the time of signing informed consent through 100 days post-transplant. Fertility preservation method will be left to treating physician's discretion. Exclusion Criteria: 1. Patients with known sensitivity to dimethyl sulfoxide, dextran 40, gentamicin, human serum albumin or bovine material 2. Presence of a donor-specific antibodies with MFI \>2000 3. Uncontrolled bacterial, fungal or viral infection 4. Treatment with any other investigational medical product (medications without any known FDA approved indication) needs to be discussed with the PI for patient eligibility.
Contact & Investigator
Sanghee Hong, MD
PRINCIPAL INVESTIGATOR
Duke Health
Frequently Asked Questions
Who can join the NCT06731504 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06731504 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06731504 currently recruiting?
Yes, NCT06731504 is actively recruiting participants. Contact the research team at sanghee.hong@duke.edu for enrollment information.
Where is the NCT06731504 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06731504 clinical trial?
NCT06731504 is sponsored by Duke University. The principal investigator is Sanghee Hong, MD at Duke Health. The trial plans to enroll 10 participants.