Phase I-II Study of Abatacept with High-Dose Post-Transplant Cyclophosphamide and Bortezomib to Prevent Graft-Versus-Host Disease After Allogeneic Stem Cell Transplant

What this Trial Is About

Researchers are studying the use of abatacept combined with post-transplant cyclophosphamide PTCy and bortezomib to prevent graft-versus-host disease GVHD after allogeneic hematopoietic stem cell transplantation HSCT in adults with blood cancers. The study is conducted in two phases a phase I dose-escalation to find the maximum tolerated dose of abatacept and a phase II evaluation in two groups based on donor matching. Participants must meet institutional criteria and have matched or partially matched donors. Participants receive a standard conditioning regimen followed by peripheral blood stem cell transplants. Those with unrelated donors also get rabbit anti-thymocyte globulin rATG. The study drugsPTCy, bortezomib, and abataceptare given as GVHD prevention. The phase II dose of abatacept is determined from phase I results. Participants are grouped by donor type matched sibling, matched unrelated, or mismatched unrelated donors. Throughout the study, participants are monitored for safety and treatment effects, including determining the maximum tolerated dose of abatacept over up to two years. They undergo regular assessments per standard care protocols and study procedures. The study is open-label and non-randomized, with no placebo group. Participants must be available for the full duration and comply with all study procedures.

A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)