Clinical Trial 20877

Study Title

A Phase Ib /Randomized Phase III Trial of Patients with Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation with Either Orca-T, a T-cell-Depleted Graft with Additional Infusion of Conventional T cells and Regulatory T cells, or Standard-of-Care Allogeneic Graft

Summary

This study will evaluate the safety, tolerability, and efficacy of an engineered donor graft ("TregGraft"/"Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

Objective

Primary: To characterize the safety of administration of conventional T cells (Tcon) and regulatory T cells (Treg) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) with HLA matched donors (related or unrelated) using a T cell depleted graft [CD34+ hematopoietic stem and progenitor cells ( CD34+ HSPC )], collectively referred to as TregGraft, with single agent GVHD prophylaxis. Secondary: To determine the 1-year overall survival (OS), and graft-versus-host-disease-free and relapse-free survival (GRFS) in patients undergoing allogeneic HCT with matched donors; To measure the incidence and severity of acute and chronic graft vs host disease (GvHD); To measure incidence of serious infections; To measure incidence and timing of engraftment