RecruitingEarly Phase 1NCT07126782

The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT

Clinical Study on the Efficacy and Safety of Allogeneic γδ T Cells in the Treatment of Patients With MRD-positive Acute Myeloid Leukemia (AML) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

10 participants

Start Date

Jul 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of allogeneic γδ T cells in patients with MRD-positive AML after allo-HSCT.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of immune cell therapy — using donor gamma delta T cells — to treat patients with acute myeloid leukemia (AML) who still have traces of cancer in their blood or bone marrow (called MRD, or measurable residual disease) after a stem cell transplant. **You may be eligible if...** - You are 18 or older - You have been diagnosed with AML (based on standard classification criteria) - You have received an allogeneic (donor) stem cell transplant - Your risk level is considered favorable to intermediate - Tests show small amounts of remaining cancer (MRD-positive) - Your graft-versus-host disease (immune reaction to the transplant) is not currently active - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your leukemia has come back (5% or more blasts in blood or bone marrow) - You have active graft-versus-host disease - You have active HIV, hepatitis B or C, CMV, or EBV infections - You have unstable heart disease or a recent heart attack - You have other active cancers - You participated in another clinical study in the past 30 days 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

BIOLOGICALEx-vivo expanded allogeneic γδ T cells

Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδ T cells from donors will be adoptively transfused.


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Beijing, China

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NCT07126782


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