RecruitingPhase 1NCT06551584

Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT

Phase I Trial for Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation From an HLA-Mismatched Donor (7/8) With Orca-T


Sponsor

Stanford University

Enrollment

24 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study goal is to characterize the safety of the combination of Orca-T with dual agent GVHD prophylaxis.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I trial testing a new approach to stem cell transplantation for people with blood cancers (leukemia or myelodysplastic syndrome). It uses a specialized type of immune cell called regulatory T cells (Tregs) to try to reduce dangerous transplant side effects, like graft-versus-host disease, without suppressing the beneficial anti-cancer effects of the transplant. **You may be eligible if...** - You are 18–70 years old with acute leukemia in remission, or with myelodysplastic syndrome (MDS) eligible for transplant - You have a donor who is a close (7/8) HLA match - Your heart, lungs, liver, and kidneys are functioning adequately - You have never had a prior stem cell transplant **You may NOT be eligible if...** - You have had a previous allogeneic (donor) stem cell transplant - You are currently on immune-suppressing medications (beyond low-dose steroids) - You have active uncontrolled infection, HIV, or active hepatitis B or C - You have had a heart attack or stroke in the last 6-12 months - You have another active cancer (besides non-melanoma skin cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGORCA-T

On Day 0, participants will receive an infusion of Orca-T HSPCs and Orca-T Tregs. On Day +2 or +3 (between approximately 48 to 72 hours of Day 0), patients will receive an infusion of the Orca-T Tcons. There is no dose escalation or de-escalation planned for the Orca-T investigational product.


Locations(1)

Stanford University

Palo Alto, California, United States

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NCT06551584


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