Study on Reduced Intensity or Nonmyeloablative Conditioning with Orca-T for Acute Myelogenous Leukemia and Myelodysplastic Syndrome

Sponsor: Orca Biosystems, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07216443

This clinical trial is testing the safety and effectiveness of a new treatment called Orca-T for patients with certain blood cancers who are undergoing a type of stem cell transplant that uses less intense preparation.

Patient Parameters

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Program Overview

The study is exploring a new treatment called Orca-T, which is used in patients with blood cancers like acute myelogenous leukemia and myelodysplastic syndrome. Orca-T is a special type of stem cell and T-cell therapy made from a donor's blood. It includes different types of cells that help the body fight cancer. The trial aims to see if Orca-T is safe and effective when used with a less intense form of stem cell transplant, which is easier on the body than traditional methods.

Description

This study involves patients with acute myelogenous leukemia or myelodysplastic syndrome who cannot undergo high-intensity stem cell transplants. Instead, they will receive a less intense or non-myeloablative transplant using Orca-T, a treatment made from donor blood cells. The trial will take place at multiple centers and will not involve random assignment of treatments. Participants will receive Orca-T after a chosen preparation regimen and a medication to prevent graft-versus-host disease, a common complication of transplants. Previous studies have shown promising results, leading to further evaluation of Orca-T in this setting.

Eligibility Criteria

Inclusion Criteria

Must be 18 years or older.
Diagnosed with acute myeloid leukemia or myelodysplastic syndrome in remission or with minimal disease.
Planned to undergo a specific type of stem cell transplant with reduced intensity or non-myeloablative preparation.
Have a sibling or unrelated donor who is a perfect match for certain genetic markers.
Have adequate kidney, heart, and lung function.
Women of childbearing potential must test negative for pregnancy.
Have normal liver function tests within specified limits.
Not eligible for a fully intense stem cell transplant.

Exclusion Criteria

Have had a previous stem cell transplant.
Currently taking certain immune-suppressing medications, except for low-dose steroids.
Planned to receive additional donor cell infusions or T-cell depletion.
Have antibodies against the donor's cells.
Have a low performance score indicating poor health.
Have a high comorbidity index for certain transplant types.
Have uncontrolled infections at the time of enrollment.
Test positive for certain viral infections unless treated and cleared.
Have allergies to specific medications or proteins.
Have uncontrolled autoimmune diseases.
Have another active cancer within the past year, except for certain skin cancers.
Have social or psychological issues that prevent participation.
Women who are pregnant or breastfeeding.
Not willing to use birth control or abstain from sex for a year after transplant.
Have any serious medical conditions that could affect participation or results.

Locations

FACILITY	ZIP	CITY	STATE
UCLA Department of Medicine	90095	Los Angeles	California
John Theurer Cancer Center at Hackensack University Medical Center	07601	Hackensack	New Jersey
Oregon Health and Science University	97239	Portland	Oregon
Vanderbilt University Medical Center	37221	Nashville	Tennessee

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