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Trial for Advanced Blood Cancers Using ORCA-T

This study is for people aged 18 to 70 with advanced blood cancers like acute myeloid leukemia (AML), acute lymphoid leukemia (ALL), mixed phenotype acute leukemia, or myelodysplastic syndromes (MDS) who are undergoing a stem cell transplant (allogeneic HCT). The study is testing the safety of a treatment called ORCA-T, which involves infusions of different types of cells (HSPCs, Tregs, and Tcons) around the time of your transplant. The main goal is to see how many patients do not have severe transplant-related side effects within 100 days after the transplant. We are looking to enroll 24 participants, but the current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 24 participants. The phase of the study is not specified.
What's involved
Participants will receive infusions of Orca-T HSPCs and Orca-T Tregs on Day 0, and Orca-T Tcons on Day +2 or +3 after Day 0.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures outcomes at Day +100, with measurement taken at 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06551584

Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Stanford University
~24 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:ORCA-T

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Patients Without Severe Transplant-Related Adverse Events at Day +100
Measured over 18 months

Conditions

Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Mixed Phenotype Acute Leukemia
Myelodysplastic Syndromes

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaHematologic NeoplasmMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeHLA Complex

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Lori Muffly · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Alyssa Kanegai
[email protected]
(650) 736-1596
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) as defined in Section 6.1.3; with or without the presence of known minimal residual disease, or
Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT and/or treatment-related MDS \<10% blasts 2. Age ≥ 18 and ≤ 70 years at the time of enrollment. 3. Eligible for myeloablative alloHCT including one of two the myeloablative conditioning regimens (fractionated total body irradiation plus cyclophosphamide or busulfan, fludarabine, and thiotepa) 4. Has a related or unrelated donor available who is 7/8 match (single allele mismatched) at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods. 5. Estimated glomerular filtration rate (eGFR) ≥ 50 mL/minute or creatinine \< 2 mg/dL. 6. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA). 7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%. 8. Total bilirubin \< 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded). 9. Ability to understand and the willingness to provide written informed consent. 10. Negative serum or urine beta-HCG test in females of childbearing potential (FCBP) within 3 weeks of enrollment.

What this trial measures

  • Proportion of Patients Without Severe Transplant-Related Adverse Events at Day +10018 months

    The proportion of patients who, at Day +100 have not experienced any severe transplant-related adverse events including non-relapse mortality (NRM), primary graft failure, acute GVHD (grade 2-4), acute GVHD grade 3-4, or opportunistic infections (grade 4-5).