NCT07216443 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
| NCT ID | NCT07216443 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Orca Biosystems, Inc. |
| Condition | Leukemia, Myeloid, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-12-09 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years at the time of enrollment 2. Diagnosed with 1 of the following diseases: 1. Acute myeloid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease. 2. Myelodysplastic syndrome that is indicated for alloHCT per the 2017 International Expert Panel recommendations and/or therapy-related/secondary MDS as defined by the World Health Organization (WHO) classification of myeloid malignancies, with ≤10% blast burden in the bone marrow. 3. Planned to undergo 1 of the following preparative regimens as per Investigator discretion: 1. RIC cohort: Planned RIC-alloHCT including RIC regimen with TBI/thiotepa/fludarabine 2. NMA cohort: Planned NMA-alloHCT including NMA regimen with fludarabine/cyclophosphamide/TBI 4. Identified related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and -DRB1 5. Estimated glomerular filtration rate ≥30 mL/minute 6. Cardiac ejection fraction at rest ≥40% or shortening fraction of ≥22% by echocardiogram or radionuclide scan (MUGA) 7. Diffusing capacity of the lung for carbon monoxide (adjusted for hemoglobin) ≥40% 8. Negative serum or urine β-HCG test in persons of childbearing potential 9. Alanine transaminase (ALT)/aspartate transaminase (AST) \<5 times the upper limit of normal (ULN) 10. Total bilirubin \<3 × ULN 11. Deemed ineligible for a fully myeloablative alloHCT per assessment of the principal investigator Exclusion Criteria: 1. Prior alloHCT 2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed. 3. Planned donor lymphocyte infusion (DLI) 4. Planned pharmaceutical in vivo or ex vivo T-cell depletion 5. Recipient-positive antidonor HLA antibodies against a mismatched allele in the selected donor 6. Karnofsky performance score \<60% 7. For RIC cohort only: HCT-Specific Comorbidity Index (HCT-CI) ≥6 8. Uncontrolled bacterial, viral, or fungal infection (currently taking antimicrobial therapy and with progression or no clinical improvement) at the time of enrollment 9. Seropositive for HIV-1 or -2, HTLV-1 or -2, hepatitis B surface antigen, or HCV antibody unless previously treated with curative therapy and are HCV NAT negative 10. Known allergy or hypersensitivity to or intolerance of tacrolimus 11. Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal, or Streptomyces avidinii proteins 12. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment 13. Concurrent malignancy within 1 year except nonmelanoma skin cancer that has been curatively resected 14. Psychosocial circumstances that preclude the participant being able to go through transplantation or participate responsibly in follow-up care 15. Persons who are pregnant or breastfeeding 16. Person of childbearing potential (POCBP) or men who have sexual contact with POCBP who are unwilling to use effective forms of birth control or abstinence for 1 year after transplantation. 17. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or medical monitor's judgment, precludes the recipient's safe participation in and completion of the trial or which could affect compliance with the protocol or interpretation of results
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07216443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Leukemia, Myeloid, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07216443 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07216443 currently recruiting?
Yes, NCT07216443 is actively recruiting participants. Contact the research team at info@orcabio.com for enrollment information.
Where is the NCT07216443 trial being conducted?
This trial is being conducted at Los Angeles, United States, Tampa, United States, Hackensack, United States, Portland, United States and 1 additional location.
Who is sponsoring the NCT07216443 clinical trial?
NCT07216443 is sponsored by Orca Biosystems, Inc.. The trial plans to enroll 80 participants.
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