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

NCT07126782 | Recruiting Early Phase 1 DMC

• 1 other identifier: IIT2025056
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AML (Acute Myelogenous Leukemia); AML

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Defined as the MRD-negative complete remission rate (CRMRD- rate) at 4 weeks, representing the proportion of subjects achieving MRD negativity after 4 weeks of treatment.

  4weeks

Secondary Outcomes (4)

• MRD-negative rate at 2 weeks (CRMRD- rate)

  2weeks

• Duration of Response (DOR)

  4weeks

• 2-Year Overall Survival (OS)

  2 years

• Safety observation

  Baseline to 2 years

Study Arms (1)

Allogeneic γδ T cell immunotherapy

EXPERIMENTAL

Patients will receive at least 4 cycles of in vitro extended allogeneic γδ T cell therapy, twice a week.

Biological: Ex-vivo expanded allogeneic γδ T cells

Interventions

Ex-vivo expanded allogeneic γδ T cells BIOLOGICAL

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.

Allogeneic γδ T cell immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.
• Age≥18 years old, gender unlimited.
• All the subjects met the 2016 WHO classification and were diagnosed with AML via MICM (Morphology,Immunophenotyping, Cytogenetics, and Molecular genetics).
• AML patients receiving allo-HSCT.
• Subjects classified into the favorable -to-intermediate risk group according to the 2022 European Leukemia Net (ELN) risk stratification guidelines.
• All subjects were detected positive for MRD, and MRD was positive by flow cytometry (MFC) or/and positive for fusion genes/gene mutations by RQ-PCR.
• ECOG performance status score: 0-2.
• Inactive GVHD (acute GVHD grade II-IV or moderate to severe chronic GVHD).
• Adequate bone marrow reserve, defined as: absolute neutrophil count (ANC) \> 0.5E9/L and platelet count ≥20E9/L.
• Adequate organ function as per protocol.
• Male and female patients of reproductive potential must agree to use birth control during the study and for at least 28 days post study.

You may not qualify if:

• Post-transplant relapse or extramedullary disease: AML patients post-allo-HSCT with ≥5% blasts in peripheral blood or bone marrow (excluding causes such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia infiltration.
• Active GVHD: Subjects with active GVHD within 30 days before screening.
• Active infections: HBV, HCV, HIV, syphilis (TP), active CMV, or EBV infection.
• Neurological disorders: active autoimmune or inflammatory neurological diseases, clinically significant active cerebrovascular disease.
• Unstable systemic diseases, including: unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months before screening), myocardial infarction (within 6 months before screening), NYHA Class III/IV heart failure, refractory hypertension (defined as failure to control blood pressure despite lifestyle modifications and treatment with ≥4 antihypertensive drugs, including diuretics, for \>1 month), clinically significant arrhythmias requiring medication, severe hepatic, renal, or metabolic disorders.
• Major surgery: Subjects who underwent major surgery within 4 weeks before screening, as deemed ineligible by the investigator.
• Concurrent non-hematologic malignancies.
• Cardiac abnormalities, meeting any of the following: Left ventricular ejection fraction (LVEF) ≤45%. NYHA Class III/IV congestive heart failure. QTc interval \>480 msec. Other cardiac conditions considered unsuitable by the investigator.
• History of epilepsy or other active CNS disorders.
• Uncontrolled infections: active systemic infections requiring treatment (e.g., sepsis, bacteremia, fungemia, tuberculosis, opportunistic infections).
• Recent participation in other interventional trials: Subjects who participated in another interventional clinical study within 30 days prior to enrollment.
• Other conditions: Any other circumstances deemed by the investigator to compromise subject safety or trial integrity.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Erlie Jiang, M.D.;Ph.D

CONTACT

022-23909180; jiangerlie@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): July 20, 2028
• Last Updated: August 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)