Expanded antigen-specific donor regulatory T cells for GVHD prevention.
Joseph Pidala, Nicoletta Cieri, Michael J Schell et al.
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In 30 seconds
This phase 1 clinical trial evaluated the safety and preliminary efficacy of expanded minor histocompatibility antigen (mHAg)-specific donor regulatory T cells (Treg) for preventing graft-versus-host disease (GVHD) in 15 patients undergoing allogeneic hematopoietic cell transplantation. The maximum tolerated dose was determined to be 4 × 10^5/kg, with a day 100 cumulative incidence of grade II to IV acute GVHD at 13%.
Key findings
- No dose-limiting toxicities were observed across all dose levels.
- The day 100 cumulative incidence of grade II to IV acute GVHD was 13%.
- Moderate/severe chronic GVHD rates were 6.7% at 1 year and 20% at 3 years.
- Overall survival at the median follow-up of 41.7 months was 73%.
Why it matters
The findings suggest that mHAg-specific expanded donor Treg may provide a safe and effective strategy for GVHD prevention, potentially improving outcomes in patients undergoing allogeneic hematopoietic cell transplantation.