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OncoMatch/Clinical Trials/NCT03802695

A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Is NCT03802695 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies OrcaGraft (Orca-Q) for acute myeloid leukemia.

Phase 1RecruitingOrca Biosystems, Inc.NCT03802695Data as of May 2026

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

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Acute Lymphoblastic Leukemia

Prior therapy

Cannot have received: allogeneic hematopoietic stem cell transplant

Prior alloHCT

Lab requirements

Kidney function

eGFR > 50 mL/min (MAC with tacrolimus) or > 30 mL/min (NMA/RIC or MAC without tacrolimus)

Liver function

Total bilirubin < 1.5x ULN (MAC) or < 3x ULN (NMA/RIC); ALT/AST < 3x ULN (MAC) or < 5x ULN (NMA/RIC)

Cardiac function

Ejection fraction ≥ 45% (MAC) or ≥ 40% (NMA/RIC)

eGFR > 50 mL/minute (MAC with tacrolimus) or > 30 mL/minute (NMA/RIC or MAC without tacrolimus) Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA/RIC) DLCO (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA/RIC Liver function: Total bilirubin < 1.5x ULN (MAC) or < 3x ULN (NMA/RIC); ALT/AST < 3x ULN (MAC) or < 5x ULN (NMA/RIC)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope · Duarte, California
  • UC Davis · Sacramento, California
  • Stanford Health Care · Stanford, California
  • Moffitt Cancer Center · Tampa, Florida
  • Emory University · Atlanta, Georgia

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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