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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ex-vivo expanded allogeneic γδ T cells

Treatment groups

10 Participants
are divided into 1 treatment group