Actively Recruiting
Clinical Study on the Efficacy and Safety of Allogeneic Gamma Delta T Cells in Treating MRD-positive Acute Myeloid Leukemia After Stem Cell Transplantation
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-17
10
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of allogeneic gamma delta (γδ) T cells in adults with measurable residual disease (MRD)-positive acute myeloid leukemia (AML) after receiving an allogeneic hematopoietic stem cell transplantation (allo-HSCT). This early-phase, single-center, randomized clinical trial aims to understand how well these specially prepared immune cells work in this specific patient group. Participants will receive infusions of ex-vivo expanded allogeneic γδ T cells sourced from healthy donors. These cells are expanded and activated outside the body before being transfused into patients at doses of either 2 x 10^8 or 4 x 10^8 cells per kilogram. Patients will undergo at least four cycles of this T cell therapy, with treatments administered twice a week. During the study, participants will be monitored closely for treatment response, including objective response rate at four weeks and MRD-negative rates at two weeks. Researchers will also observe the duration of response, overall survival over two years, and safety throughout the study period. Assessments include regular clinical evaluations, laboratory tests, and safety observations to track the effects and any adverse events related to the therapy.
CONDITIONS
Brief Title
The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily sign an informed consent form before the trial.
- Age 18 years or older, any gender.
- Diagnosed with AML according to the 2016 WHO classification via morphology, immunophenotyping, cytogenetics, and molecular genetics.
- Have received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Classified as favorable to intermediate risk according to 2022 European Leukemia Net guidelines.
- Positive measurable residual disease detected by flow cytometry or gene mutation testing.
- ECOG performance status score between 0 and 2.
- No active graft-versus-host disease (grade II-IV acute or moderate to severe chronic GVHD).
- Adequate bone marrow reserve: absolute neutrophil count greater than 0.5E9/L and platelet count at least 20E9/L.
- Adequate organ function as defined by the study protocol.
- Men and women of reproductive potential must agree to use birth control during and for 28 days after the study.
You will not qualify if you...
- Relapse after transplant or extramedullary disease with 5% or more blasts in blood or bone marrow.
- Active graft-versus-host disease within 30 days before screening.
- Active infections including HBV, HCV, HIV, syphilis, CMV, or EBV.
- Active autoimmune or inflammatory neurological diseases or significant cerebrovascular disease.
- Unstable systemic diseases such as unstable angina, recent stroke or heart attack, severe heart failure, refractory hypertension, significant arrhythmias, or severe liver, kidney, or metabolic disorders.
- Major surgery within 4 weeks before screening.
- Concurrent non-hematologic cancers.
- Certain cardiac abnormalities like low ejection fraction, severe heart failure, prolonged QTc interval, or other concerning conditions.
- History of epilepsy or active central nervous system disorders.
- Uncontrolled systemic infections needing treatment.
- Participation in another interventional trial within 30 days before enrollment.
- Any other conditions that might compromise safety or study integrity as determined by the investigator.
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.
Duration - Approximately 2 weeks
Participants receive at least 4 cycles of ex-vivo expanded allogeneic γδ T cell therapy administered twice a week.
At least 8 visits (twice a week for 4 cycles)
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes including response and overall survival.
Periodic visits during 2 years
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Beijing, China
Actively Recruiting
Research Team
E
Erlie Jiang, M.D.;Ph.D
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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