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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

This study will evaluate the safety, tolerability, and efficacy of an engineered donor graft
("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.
Leukemia, Myelodysplastic Syndrome, Phase I
Phase I
Adults
Bone Marrow/Stem Cell Transplant
TregGraft
Dholaria, Bhagirathbhai
International
Vanderbilt University
07-16-2021
Treatment
VICCCTTP2086
NCT04013685

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

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 that is not in CR/CRi [Ages 18-65] - myelodysplastic syndromes with > 10% to 1 first- or second-generation TKI [Ages 18-65] 2. Patients must be matched to a 8/8 HLA-matched related or unrelated donor 3. Estimated glomerular filtration rate (eGFR) > 50 mL/minute 4. Cardiac ejection fraction at rest 45% or shortening fraction of 27% by echocardiogram or radionuclide scan (MUGA) 5. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) 50% 6. Total bilirubin 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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