Tests donor-derived immune cells in leukemia patients after stem cell transplant
Tests immune cells grown outside the body in adults with acute myeloid leukemia after transplant.
Plain-language title generated from the registry record
Registry title: The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukemia (AML) who had a donor stem cell transplant and still show tiny traces of leukemia (MRD-positive). It tests donor-derived γδ T cells.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- AML after allogeneic stem cell transplant (allo-HSCT), in the favorable-to-intermediate risk group (2022 ELN). MRD-positive by flow cytometry or by RQ-PCR for fusion genes or gene mutations. ECOG performance status 0-2. No active GVHD.
- Earlier treatment
- Must have had an allogeneic hematopoietic stem cell transplant (allo-HSCT). Bone marrow reserve must be adequate: ANC > 0.5E9/L and platelets ≥20E9/L.
- Biomarker or test result
- MRD must be positive, by flow cytometry (MFC) or by RQ-PCR for fusion genes or gene mutations.
Main reasons for not taking part
- Relapse after transplant: 5% or more blasts in blood or bone marrow, or leukemia outside the bone marrow
- Active GVHD within 30 days before screening
- Active infection: HBV, HCV, HIV, syphilis, CMV or EBV
- Heart problems such as LVEF ≤45% or NYHA Class III/IV heart failure
- Another cancer that is not a blood cancer
Read by machine on 12 November 2026.
Where in China
- Institute of Hematology & Blood Diseases HospitalBeijing, ChinaContact: Erlie Jiang, M.D.;Ph.DTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT07126782
- Record updated
- 17 August 2025
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: Active GVHD: Subjects with active GVHD within 30 days before screening; 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; Recent participation in other interventional trials: Subjects who participated in another interventional clinical study within 30 days prior to enrollment; 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 infections: HBV, HCV, HIV, syphilis (TP), active CMV, or EBV infection; Neurological disorders: active autoimmune or inflammatory neurological diseases, clinically significant active cerebrovascular disease; History of epilepsy or other active CNS disorders; Uncontrolled infections: active systemic infections requiring treatment (e.g., sepsis, bacteremia, fungemia, tuberculosis, opportunistic infections); Other conditions: Any other circumstances deemed by the investigator to compromise subject safety or trial integrity; 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.