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 (Jun 2026). This Phase 2 trial studies Orca-T for leukemia, myeloid, acute.
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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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 →Frequently asked questions
Is NCT07216443 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic cell transplant disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify