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Clinical Trial 20877

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04013685

Phase: Phase I
Principal Investigator: Faramand, Rawan

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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


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



Therapy (NOS)


FK506 (Tacrolimus); Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus (); Tacrolimus ()

Inclusion Criteria

Key Inclusion Criteria:

  • 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
  • Estimated glomerular filtration rate (eGFR) > 50 mL/minute
  • 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%
  • Total bilirubin > Other criteria apply

  • Exclusion Criteria

    Key Exclusion Criteria:

  • History of prior allogeneic HCT
  • 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
  • Karnofsky performance score > Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4
  • 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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