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A Phase 1 Study of Engineered Donor Grafts (OrcaGraft/Orca-Q) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Status
Active
Cancer Type
Cancer-Related Syndrome
Leukemia
Myelodysplastic Syndromes (MDS)
Trial Phase
Phase I
Eligibility
18 - 65 Years, Male and Female
Study Type
Treatment
NCT ID
NCT03802695
Protocol IDs
OGFT001-001 (primary)
NCI-2019-01953
Study Sponsor
Orca Biosystems, Inc.

Summary

This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts
("OrcaGraft"/"Orca-Q") in participants undergoing myeloablative allogeneic hematopoietic cell
transplant transplantation for hematologic malignancies.

Eligibility

  1. Age = 18 and = 65 years at the time of enrollment
  2. Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia, or high or very high risk myelodysplasic syndrome (MDS) or Myelofibrosis
  3. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
  4. Matched to a related or unrelated donor or to a haploidentical donor
  5. Estimated glomerular filtration rate (eGFR) > 50 mL/minute
  6. Cardiac ejection fraction at rest = 45% or shortening fraction of = 27% by echocardiogram or radionuclide scan (MUGA)
  7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) = 50%
  8. Total bilirubin < 1.5 times upper limit of normal (ULN) (< 3 times if attributed to Gilbert's syndrome) and ALT/AST < 3 times ULN

Treatment Sites in Georgia

Emory University Hospital - Atlanta


1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.