Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologi… (NCT04013685) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
United States255 participantsStarted 2019-11-21
Plain-language summary
This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients must diagnosed with one of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned:
✓. Patients must be matched to a 8/8 HLA-matched related or unrelated donor
✓. 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 \< 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
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.
✕. 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 \< 70%
✕. 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