HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT

NCT ID: NCT06731504

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-12
• Study Completion Date: 2028-07-31

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.

Conditions

Hematologic Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) following omidubicel HCT

Abatacept 10 mg/kg is given on day -1, +5, +14, and +28 in combination with standard of care tacrolimus and mycophenolate mofetil-based GVHD prophylaxis. This regimen will follow an omidubicel transplantation.

Group Type: EXPERIMENTAL

Abatacept

Intervention Type: DRUG

Abatacept is a monoclonal antibody that suppresses T-cell activation through costimulatory blockade. In 2021, abatacept was FDA approved to prevent acute GVHD following allogeneic HCT.

Interventions

Abatacept

Abatacept is a monoclonal antibody that suppresses T-cell activation through costimulatory blockade. In 2021, abatacept was FDA approved to prevent acute GVHD following allogeneic HCT.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanghee Hong, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke University Health System

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sanghee Hong, MD

Role: CONTACT

sanghee.hong@duke.edu

9196848694

Lauren Hill

Role: CONTACT

lauren.hill@duke.edu

9196682369

Facility Contacts

Jennifer Tichon

Role: primary

jennifer.tichon@duke.edu

919-660-7262

Other Identifiers

Pro00116015

Identifier Type: -

Identifier Source: org_study_id