NCT07126782 The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT
| NCT ID | NCT07126782 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | AML (Acute Myelogenous Leukemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-07-20 |
| Primary Completion | 2027-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-07-20 with a primary completion date of 2027-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study. 2. Age≥18 years old, gender unlimited. 3. All the subjects met the 2016 WHO classification and were diagnosed with AML via MICM (Morphology,Immunophenotyping, Cytogenetics, and Molecular genetics). 4. AML patients receiving allo-HSCT. 5. Subjects classified into the favorable -to-intermediate risk group according to the 2022 European Leukemia Net (ELN) risk stratification guidelines. 6. 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. 7. ECOG performance status score: 0-2. 8. Inactive GVHD (acute GVHD grade II-IV or moderate to severe chronic GVHD). 9. Adequate bone marrow reserve, defined as: absolute neutrophil count (ANC) \> 0.5E9/L and platelet count ≥20E9/L. 10. Adequate organ function as per protocol. 11. 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 Criteria: 1. 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. 2. Active GVHD: Subjects with active GVHD within 30 days before screening. 3. Active infections: HBV, HCV, HIV, syphilis (TP), active CMV, or EBV infection. 4. Neurological disorders: active autoimmune or inflammatory neurological diseases, clinically significant active cerebrovascular disease. 5. 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. 6. Major surgery: Subjects who underwent major surgery within 4 weeks before screening, as deemed ineligible by the investigator. 7. Concurrent non-hematologic malignancies. 8. 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. 9. History of epilepsy or other active CNS disorders. 10. Uncontrolled infections: active systemic infections requiring treatment (e.g., sepsis, bacteremia, fungemia, tuberculosis, opportunistic infections). 11. Recent participation in other interventional trials: Subjects who participated in another interventional clinical study within 30 days prior to enrollment. 12. Other conditions: Any other circumstances deemed by the investigator to compromise subject safety or trial integrity.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07126782 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML (Acute Myelogenous Leukemia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07126782 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07126782 currently recruiting?
Yes, NCT07126782 is actively recruiting participants. Contact the research team at jiangerlie@ihcams.ac.cn for enrollment information.
Where is the NCT07126782 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07126782 clinical trial?
NCT07126782 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 10 participants.
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