Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acu… (NCT07216443) | Clinical Trial Compass
RecruitingPhase 2
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
United States80 participantsStarted 2025-12-09
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years at the time of enrollment
✓. Diagnosed with 1 of the following diseases:
✓. 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.
✓. 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.
✓. Planned to undergo 1 of the following preparative regimens as per Investigator discretion:
✓. RIC cohort: Planned RIC-alloHCT including RIC regimen with TBI/thiotepa/fludarabine
✓. NMA cohort: Planned NMA-alloHCT including NMA regimen with fludarabine/cyclophosphamide/TBI
✓. Identified related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and -DRB1
Exclusion criteria
What they're measuring
1
RIC Cohort: GVHD-free and relapse-free survival (GRFS)
Timeframe: Day 0 through day +365 after transplantation
2
NMA Cohort: Incidence of neutrophil engraftment
Timeframe: Day 0 through day +28 after transplantation
3
NMA Cohort: Time to neutrophil engraftment
Timeframe: Day 0 through day +28 after transplantation
✕. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
✕. Planned donor lymphocyte infusion (DLI)
✕. Planned pharmaceutical in vivo or ex vivo T-cell depletion
✕. Recipient-positive antidonor HLA antibodies against a mismatched allele in the selected donor
✕. Karnofsky performance score \<60%
✕. For RIC cohort only: HCT-Specific Comorbidity Index (HCT-CI) ≥6
✕. Uncontrolled bacterial, viral, or fungal infection (currently taking antimicrobial therapy and with progression or no clinical improvement) at the time of enrollment