Early phase 1: testing Abatacept for Hematologic Malignancy

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Abatacept. The registry lists allocation as na. This study is a single-center, non-randomly assigned, 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.

They plan to enroll about 10 people at Durham. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Abatacept

Primary outcome (registry wording): Safety of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as evaluated by frequency of adverse events.

Who it is for (from inclusion criteria)

• Ages 18 Years to any
• 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;