Phase 1 Study Evaluating Orca-Q Donor Grafts in Patients Aged 12-78 Undergoing Allogeneic Stem Cell Transplant for Blood Cancers

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of engineered donor grafts called OrcaGraft or Orca-Q in participants undergoing allogeneic hematopoietic cell transplantation for blood cancers such as acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia, and high-risk myelodysplastic syndromes. This phase 1 study focuses on participants aged 12 to 78 who are matched to related or unrelated donors for stem cell transplant using different conditioning regimens and graft-versus-host disease prevention strategies. Participants receive OrcaGraft donor cells during their allogeneic transplant procedure. The study includes several groups based on donor matching and conditioning intensity, with some receiving myeloablative conditioning and others reduced intensity conditioning. Graft-versus-host disease prophylaxis varies from none to single or dual agents depending on the group. The study examines dose escalation and expansion cohorts to assess safety and graft success. During the study, participants are closely monitored through Day 365 after receiving OrcaGraft. Researchers will assess dose limiting toxicities and graft failure within the first 28 days, as well as neutrophil and platelet recovery, graft-versus-host disease occurrence, relapse rates, survival, and other clinical outcomes up to one year post-transplant. Regular tests, clinical evaluations, and laboratory assessments are performed to track participant health and transplant success throughout the follow-up period.

A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies