Abatacept for GVHD Prevention After Omidubicel Transplant
This study is looking at a new way to prevent graft-versus-host disease (GVHD) after a special type of stem cell transplant called omidubicel HCT. GVHD is a complication where the new immune cells attack your body. Researchers are testing a combination of medicines: abatacept, tacrolimus, and mycophenolate mofetil (ABA/Tac/MMF). Abatacept works by calming down certain immune cells (T-cells). This pilot study aims to see how safe and practical this treatment combination is. They plan to enroll 10 adult patients who have a blood cancer (hematologic malignancy) and are eligible for an omidubicel transplant. The study is currently recruiting participants.
- Study design
- This is a small pilot study involving 10 adult participants. It is a single-arm study, meaning everyone receives the same treatment, and it is not randomized.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess safety for 6 months after the transplant and feasibility for 28 days after the transplant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
At a glance
Conditions
NCT06731504
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Duke University Health System
Durham, North Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sanghee Hong, MD · PRINCIPAL_INVESTIGATOR · Duke Health
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as evaluated by frequency of adverse events.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.
- Safety of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as evaluated by severity of adverse events.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.
- Feasibility of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as evaluated by number of subjects who receive minimum dose of ABA.Day 28 post-HCT
Minimum dose is 4 doses of minimum 10mg/kg of abatacept prophylaxis following omidubicel transplant.