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
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.
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
Matched to a related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and DRB1
Diagnosed with one of the following diseases: Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease, OR Myelodysplastic syndromes (MDS) that are high to very high risk or therapy-related/secondary MDS
Planned to undergo MA-alloHCT including one of the following myeloablative conditioning regimens: TBI/Cy, TBI/Etoposide, BFT
Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
Negative serum or urine beta-HCG test in females of childbearing potential
ALT/AST > Recipients in screening must screen negative for SARS-CoV-2 RNA using a PCR-based test
Disease Risk Index (DRI) overall risk categorization of intermediate or high
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