Phase 1 Trial of Orca-T With Dual GVHD Prevention in Adults 18-70 Undergoing Allogeneic Hematopoietic Cell Transplant for Advanced Blood Cancers

What this Trial Is About

This research aims to assess the safety of combining Orca-T with dual-agent graft-versus-host disease GVHD prevention in patients with advanced blood cancers who are undergoing allogeneic hematopoietic cell transplantation HCT from a partly matched donor. The study focuses on patients with acute myeloid leukemia, acute lymphoid leukemia, mixed phenotype acute leukemia, or myelodysplastic syndromes who are eligible for intensive transplant conditioning. Participants receive an infusion of Orca-T hematopoietic stem and progenitor cells HSPCs and regulatory T cells on the transplant day, followed by an infusion of Tcon cells 2 to 3 days later. Starting the day after Tcon infusion, patients begin dual-agent GVHD prophylaxis with tacrolimus and ruxolitinib on consecutive days. The study does not involve dose changes for Orca-T and uses a single treatment group. Throughout the study, participants are monitored to measure the proportion who avoid severe transplant-related adverse events by day 100 after transplant, with safety tracked up to 18 months. Assessments include clinical evaluations and laboratory tests to monitor organ function and complications. Participants must consent to the study and meet specific health criteria before enrollment, with the study lasting until December 2026.

Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT