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A Phase 1 Study of 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), myelofibrosis, or chronic myeloid leukemia
  3. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
  4. Matched to a 8/8 or 7/8 related or unrelated donor, or to a related 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 Key

Treatment Sites in Georgia

Emory University Hospital - Atlanta


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

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