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OncoMatch/Clinical Trials/NCT07216443

Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Is NCT07216443 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Orca-T for leukemia, myeloid, acute.

Phase 2RecruitingOrca Biosystems, Inc.NCT07216443Data as of May 2026

Treatment: Orca-T — This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons).

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Acute Lymphoblastic Leukemia

Prior therapy

Cannot have received: allogeneic hematopoietic cell transplant

Lab requirements

Kidney function

Estimated glomerular filtration rate ≥30 mL/minute

Liver function

ALT/AST <5x ULN; total bilirubin <3x ULN

Cardiac function

Ejection fraction at rest ≥40% or shortening fraction ≥22% by echocardiogram or radionuclide scan (MUGA)

Estimated glomerular filtration rate ≥30 mL/minute; Cardiac ejection fraction at rest ≥40% or shortening fraction of ≥22% by echocardiogram or radionuclide scan (MUGA); Diffusing capacity of the lung for carbon monoxide (adjusted for hemoglobin) ≥40%; ALT/AST <5x ULN; total bilirubin <3x ULN

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

US trial sites

  • UCLA Department of Medicine · Los Angeles, California
  • Moffitt Cancer Center · Tampa, Florida
  • John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, New Jersey
  • Oregon Health and Science University · Portland, Oregon
  • Vanderbilt University, Ingram Cancer Center · Nashville, Tennessee

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

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