Abatacept to prevent GVHD after omidubicel cord-blood transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, non-randomized, single-arm pilot enrolls adults with hematologic malignancies who have an available cord blood unit for omidubicel manufacturing and are planned for myeloablative conditioning. Participants receive omidubicel hematopoietic stem cell transplantation followed by abatacept plus tacrolimus and mycophenolate mofetil as graft-versus-host disease (GVHD) prophylaxis. The primary objective is to test the safety and feasibility of abatacept/tacrolimus/mycophenolate after omidubicel HCT, with abatacept pharmacokinetics and routine clinical monitoring included. Ten participants will be enrolled and followed for 18 months, with an expected accrual period of about 36 months.

Why it matters

Who can join: the full rules

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.

Where it's running

• Duke University Health System
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Sanghee Hong, MD — Duke Health
• Study coordinator: Sanghee Hong, MD
• Email: sanghee.hong@duke.edu
• Phone: 9196848694

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.