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
Patients must diagnosed with one of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned:
Acute myeloid, lymphoid or mixed phenotype leukemia
High or very high risk myelodysplastic syndromes
Myelofibrosis
Blastic Plasmacytoid Dendritic Cell Neoplasm
Patients with active acute leukemia (i.e. not in morphologic complete response) must have bone marrow infiltration by leukemic blasts of > Patients must be matched to a related or unrelated donor
Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
Pre-planned donor lymphocyte infusion (DLI)
Planned pharmaceutical in vivo or ex vivo T cell depletion
Positive for anti-donor HLA antibodies against an allele in the selected donor
Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody
Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
Women who are pregnant or breastfeeding
Other exclusions apply
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