Actively Recruiting
Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT
Led by Stanford University · Updated on 2026-01-30
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study goal is to characterize the safety of the combination of Orca-T with dual agent GVHD prophylaxis.
CONDITIONS
Official Title
Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute myeloid, lymphoid, or mixed phenotype leukemia in complete remission or myelodysplastic syndrome suitable for allogeneic transplant
- Aged between 18 and 70 years at enrollment
- Eligible for myeloablative allogeneic hematopoietic cell transplantation with approved conditioning regimens
- Have a related or unrelated donor with a 7/8 HLA match based on high-resolution typing
- Kidney function with estimated glomerular filtration rate (eGFR) of 50 mL/minute or higher or creatinine below 2 mg/dL
- Cardiac ejection fraction at rest of 45% or more or shortening fraction of 27% or more by echocardiogram or radionuclide scan
- Lung diffusing capacity for carbon monoxide (DLCO) adjusted for hemoglobin of 50% or higher
- Total bilirubin less than twice the upper limit of normal (Gilbert's syndrome allowed if hemolysis is excluded)
- Able to understand and willing to provide written informed consent
- Negative pregnancy test within 3 weeks prior to enrollment for females of childbearing potential
- Karnofsky Performance Score of 70% or higher
You will not qualify if you...
- Previous allogeneic hematopoietic cell transplant
- Currently receiving corticosteroids or immunosuppressive therapy above 10 mg/day systemic dose
- Planned donor lymphocyte infusion (DLI) or pharmaceutical T cell depletion treatments around transplant
- Positive anti-donor HLA antibodies or positive crossmatch test to donor mismatch alleles
- Uncontrolled infections including active tuberculosis
- Seropositive for HIV-1 or -2, HTLV-1 or -2, hepatitis B surface antigen, or hepatitis C antibody unless viral load undetectable
- Known allergies to investigational products or planned GVHD prophylactic medications
- Allergy to iron dextran or certain animal proteins
- Uncontrolled autoimmune diseases needing active immunosuppression
- Any new cancer diagnosed within 12 months except cured non-melanoma skin cancers
- Females of childbearing potential or men with partners of childbearing potential unwilling to use birth control for one year post-transplant
- Recent significant cardiac events or serious cardiac disease within 12 months or stroke/pulmonary embolism within 6 months
- Any serious medical condition or lab abnormality that risks safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
A
Alyssa Kanegai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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