RecruitingPhase 2NCT07216443

Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome


Sponsor

Orca Biosystems, Inc.

Enrollment

80 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing Orca-T — a specially engineered stem cell transplant product designed to reduce dangerous post-transplant immune complications — in people with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are not fit enough for a full-intensity bone marrow transplant. **You may be eligible if...** - You are 18 or older and have AML in remission or MDS with less than 10% blasts in the bone marrow - You are not eligible for a fully intensive bone marrow transplant - You have an available matched stem cell donor (8 out of 8 HLA match) - Your heart, lung, liver, and kidney function are adequate **You may NOT be eligible if...** - You have had a previous stem cell transplant - You are currently on immune-suppressing medications (low-dose topical steroids are okay) - You have active uncontrolled infections - You are HIV positive, have hepatitis B surface antigen, or have active hepatitis C - You have known allergy to tacrolimus (an anti-rejection drug) or to iron dextran - You are pregnant or breastfeeding - You have a concurrent active malignancy within the past year (except minor skin cancers) 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

BIOLOGICALOrca-T

An allogeneic stem cell and T-cell immunotherapy biologic


Locations(5)

UCLA Department of Medicine

Los Angeles, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Oregon Health and Science University

Portland, Oregon, United States

Vanderbilt University, Ingram Cancer Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07216443


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