Actively Recruiting
Phase I Trial for Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation From an HLA-Mismatched Donor With Orca-T
Led by Stanford University · Updated on 2026-01-30
24
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of combining Orca-T with dual-agent graft-versus-host disease (GVHD) prevention in patients with advanced blood cancers who are undergoing allogeneic hematopoietic cell transplantation (alloHCT) from a partially matched donor. This Phase I trial focuses on patients with acute myeloid leukemia, acute lymphoid leukemia, mixed phenotype acute leukemia, or myelodysplastic syndromes who are eligible for this transplant procedure. The study aims to better understand adverse events related to this treatment combination within the first 100 days after transplant. Participants will receive an infusion of Orca-T hematopoietic stem and progenitor cells (HSPCs) and regulatory T cells on Day 0, followed by an infusion of conventional T cells between Day 2 and 3. Beginning on Day 3 or 4, patients will start dual-agent GVHD prophylaxis with tacrolimus and ruxolitinib, administered in sequence. There is no planned dose change for Orca-T during this study. This regimen is designed to be given alongside myeloablative conditioning and transplant from a donor matched at 7 out of 8 HLA alleles. Throughout the study, researchers will monitor participants for transplant-related adverse events up to Day 100, focusing on the proportion of patients without severe complications. Patients will undergo regular assessments including kidney function, heart and lung capacity, and infection screening to ensure eligibility and safety. The full participation period includes initial treatment and follow-up over 18 months to evaluate longer-term outcomes and safety.
CONDITIONS
Brief Title
Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid, lymphoid, or mixed phenotype leukemia in remission or myelodysplastic syndromes eligible for transplant
- Age between 18 and 70 years at enrollment
- Eligible for myeloablative allogeneic hematopoietic cell transplantation with specified conditioning regimens
- Availability of a related or unrelated donor matched 7 out of 8 HLA alleles by high-resolution typing
- Kidney function with eGFR ≥ 50 mL/min or creatinine < 2 mg/dL
- Heart function with ejection fraction ≥ 45% or shortening fraction ≥ 27%
- Lung function with DLCO ≥ 50% adjusted for hemoglobin
- Total bilirubin less than twice the upper limit of normal
- Ability to understand and provide written informed consent
- Negative pregnancy test in females of childbearing potential within 3 weeks before enrollment
- Karnofsky Performance Score of 70% or higher
You will not qualify if you...
- Prior allogeneic hematopoietic cell transplantation
- Currently receiving corticosteroids or immunosuppressive therapy above low doses
- Planned donor lymphocyte infusion
- Planned pharmaceutical T cell depletion treatments without required washout
- Presence of anti-donor HLA antibodies or positive crossmatch test
- Active uncontrolled infections including tuberculosis
- Positive for HIV, HTLV, Hepatitis B or C (except controlled past infections)
- Allergy or intolerance to investigational agents or GVHD prophylaxis medications
- Allergy to iron dextran or certain animal proteins
- Uncontrolled autoimmune disease requiring treatment
- Concurrent malignancy diagnosed within past 12 months except certain skin cancers
- Unwillingness to use effective birth control or abstinence for one year post-transplant for participants of childbearing potential
- Recent significant cardiac events or stroke within specified timeframes
- Any serious medical condition or lab abnormality that precludes safe participation or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Day 0 infusion through Day +100 post-transplant
Participants receive an infusion of Orca-T cells followed by dual-agent tacrolimus and ruxolitinib for graft-versus-host disease prophylaxis.
Multiple visits including Day 0 infusion, Day +2 or +3 and Day +3 or +4 infusions, plus daily monitoring during initial treatment phase
Duration - Up to 18 months after Day +100
Participants are monitored for safety and transplant-related outcomes including adverse events up to 18 months post-treatment.
Regular follow-up visits for safety assessments and outcome monitoring
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
A
Alyssa Kanegai
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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