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NCT Number: NCT06731504

HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT

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.

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Key information

Conditions

Hematologic Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Duke University Health System

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Jennifer Tichon

CONTACT

[email protected]

919-660-7262

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing
  • Adult patients (≥18 at the time of enrollment)
  • Adequate organ function for transplant defined as:
  • Left ventricular ejection fraction ≥ 40%;
  • DLCO, FEV1, FVC > 50% predicted;
  • 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);
  • Serum creatinine within normal range, or if serum creatinine outside normal range, must have measured or estimated creatinine clearance > 40 mL/min/1.73m2;
  • Karnofsky performance score ≥ 70; and
  • If applicable, > 6 months since a previous autologous transplant.
  • 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

  • Patients with known sensitivity to dimethyl sulfoxide, dextran 40, gentamicin, human serum albumin or bovine material
  • Presence of a donor-specific antibodies with MFI >2000
  • Uncontrolled bacterial, fungal or viral infection
  • Treatment with any other investigational medical product (medications without any known FDA approved indication) needs to be discussed with the PI for patient eligibility.

Treatment and study plan

Abatacept

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.

Primary outcomes

  1. Safety of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as evaluated by frequency of adverse events.

    Time frame: 6 months post-HCT

    Adverse events are defined by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Only events related to Abatacept (and not solely expected toxicities of omidubicel HCT) will be recorded.

  2. Safety of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as evaluated by severity of adverse events.

    Time frame: 6 months post-HCT

    Adverse events are defined by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Only events related to Abatacept (and not solely expected toxicities of omidubicel HCT) will be recorded.

  3. Feasibility of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as evaluated by number of subjects who receive minimum dose of ABA.

    Time frame: Day 28 post-HCT

    Minimum dose is 4 doses of minimum 10mg/kg of abatacept prophylaxis following omidubicel transplant.

Secondary outcomes

  1. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by Severe GVHD-Free and Progression-Free Survival (SRFS).

    Time frame: 18 months post-HCT

    Severe GVHD-Free and Progression-Free Survival (SRFS) as a time to event outcome is defined as the first event of Grade III-IV acute GVHD or chronic GVHD requiring systemic immune suppression, with underlying disease progression or relapse, and death by any cause.

  2. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by rates of acute GVHD.

    Time frame: 18 months post-HCT

    Cumulative incidences of Grade II-IV and III-IV acute GVHD will be determined per Glucksberg criteria.

  3. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by rates of chronic GVHD - mild, moderate, and severe per NIH criteria.

    Time frame: 18 months post-HCT

    The cumulative incidence of chronic GVHD will be determined per NIH Consensus Conference Criteria.

  4. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by hematologic recovery.

    Time frame: 30 days post-HCT

    Hematologic recovery is defined by achieving both neutrophil and platelet count recovery after transplant. Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/mm3 for three consecutive measurements on three different days. Platelet recovery is defined as the first day of a sustained platelet count (1) greater than or equal to 20,000/mm3 or (2) greater than or equal to 50,000/mm3 with no platelet transfusions in the preceding seven days.

  5. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by rates of severe infections at 6 months post-transplant.

    Time frame: 6 months post-HCT

    The incidence of definite and probable viral, fungal, and bacterial infections will be tabulated.

  6. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by rates of viral reactivations at 6 months post-transplant.

    Time frame: 6 months post-HCT

    The cumulative incidence of treated CMV and HHV6 reactivation in the first 6 months post-transplant will be described.

  7. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by donor cell engraftment.

    Time frame: Day 28, 60, and 90 post-HCT

    Donor cell engraftment will be assessed by donor/recipient chimerism studies. Chimerism may be evaluated in bone marrow, whole unfractionated blood, or blood cell fractions, including CD3 and CD33 or CD15 fraction.

  8. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by disease relapse or progression.

    Time frame: Day 90 post-HCT

    Relapse or progression will be diagnosed by bone marrow assessment.

  9. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by non-relapse mortality (NRM).

    Time frame: Day 100, 180, and 365 post-HCT

    NRM is defined as death without evidence of disease progression or recurrence.

  10. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by disease-free survival (DFS).

    Time frame: 18 months post-HCT

    DFS is defined as the time from date of transplant to death or relapse/progression, whichever comes first.

  11. Efficacy of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as measured by overall survival (OS).

    Time frame: 18 months post-HCT

    OS is defined as the time interval between date of transplant and death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Hill

CONTACT

[email protected]

9196682369

Sanghee Hong, MD

CONTACT

[email protected]

9196848694

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

A Pilot Trial of Abatacept Based Graft-Versus-Host Disease Prophylaxis Following Omidubicel Hematopoietic Cell Transplantation

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 12, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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