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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 (Jun 2026). This Phase 1 trial studies OrcaGraft (Orca-Q) for acute myeloid leukemia.

Phase 1RecruitingOrca Biosystems, Inc.NCT03802695Data as of Jun 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

Treatments studied

Other

OrcaGraft (Orca-Q)

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Acute Lymphoblastic Leukemia

Demographics

Ages 12–78

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 →

Frequently asked questions

Is NCT03802695 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic hematopoietic stem cell transplant disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 78 years or younger and at least 12 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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