Abatacept for Blood Cancers

Overseen By Lauren Hill

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Duke University

Must not be taking: Investigational drugs

Disqualifiers: Sensitivity to dimethyl sulfoxide, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Sanghee Hong, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

Adults diagnosed with blood cancers who have a matching cord blood unit for omidubicel HCT. They must be in good enough health to undergo the procedure, with proper heart, kidney, and lung function, normal liver enzymes, and able to perform daily activities without assistance. Women of childbearing potential and men must use two forms of contraception or abstain from sex.

Inclusion Criteria

My heart pumps well enough (ejection fraction is 40% or more).

I agree to use two forms of birth control or abstain from sex as required.

My lung function tests are more than half the normal expected value.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning Chemotherapy

Participants undergo myeloablative conditioning chemotherapy of physician's choice prior to transplantation

2-3 weeks

Transplantation and GVHD Prophylaxis

Participants receive omidubicel hematopoietic stem cell transplantation followed by abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) for GVHD prophylaxis

4 weeks

Visits on day -1, +5, +14, and +28 for abatacept administration

Follow-up

Participants are monitored for safety, GVHD, and hematologic recovery post-transplant

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Abatacept

Trial Overview The trial is testing abatacept combined with tacrolimus and mycophenolate mofetil as a way to prevent graft-versus-host disease after transplanting stem cells from umbilical cord blood (omidubicel) in patients with hematologic malignancies.

How Is the Trial Designed?

Group I: Abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) following omidubicel HCT Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+