Abatacept to prevent GVHD after omidubicel cord-blood transplant

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

This trial tests whether adding abatacept with tacrolimus and mycophenolate can prevent graft-versus-host disease in adults receiving omidubicel cord-blood stem cell transplants for blood cancers.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Duke University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT06731504 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with a hematologic malignancy who are eligible for myeloablative omidubicel HCT, have an available cord blood unit for product manufacture, adequate organ function, and a Karnofsky score ≥70.

Not a fit: Patients without an available cord blood unit, those ineligible for myeloablative conditioning, with severe organ dysfunction, or under 18 are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lower rates of GVHD after cord-blood transplant, improving survival and quality of life for recipients.

How similar studies have performed: Abatacept has shown benefit in reducing acute GVHD in other donor settings, but its use specifically after omidubicel cord-blood transplantation is novel and not well studied.

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.

Where this trial is running

Durham, North Carolina

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

Study contacts

• Principal investigator: Sanghee Hong, MD — Duke Health
• Study coordinator: Sanghee Hong, MD

Conditions Hematologic Malignancy