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A Study of Engineered Donor Grafts (TregGraft/Orca-T) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase I
Eligibility
18 - 65 Years, Male and Female
Study Type
Treatment
NCT ID
NCT04013685
Protocol IDs
TRGFT-201 (primary)
NCI-2019-08529
Study Sponsor
Orca Biosystems, Inc.

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.

Eligibility

  1. Key Inclusion Criteria: Recipients must meet all of the following criteria: 1. 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 2. Patients with active acute leukemia (i.e. not in morphologic complete response) must have bone marrow infiltration by leukemic blasts of <= 10%, 3. Patients must be matched to a related or unrelated donor 4. Estimated glomerular filtration rate (eGFR) > 50 mL/minute 5. Cardiac ejection fraction at rest = 45% or shortening fraction of = 27% by echocardiogram or radionuclide scan (MUGA) 6. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) = 50% 7. Total bilirubin < 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included where hemolysis has been excluded) and ALT/AST < 3 times ULN Key Exclusion Criteria: Recipients meeting any of the following exclusion criteria will not be eligible: 1. History of prior allogeneic HCT 2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed. 3. Pre-planned donor lymphocyte infusion (DLI) 4. Planned pharmaceutical in vivo or ex vivo T cell depletion 5. Positive for anti-donor HLA antibodies against an allele in the selected donor 6. Karnofsky performance score < 70% 7. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4 8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment 9. Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody 10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment 11. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected 12. Women who are pregnant or breastfeeding
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