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Treatment of Relapsed or Refractory t(8; 21) AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL)
Sponsor: BGI, China
Summary
1. To evaluate the safety and tolerability of targeted AML1-ETO neoantigen cytotoxic T cells (CTL) in the treatment of relapsed or refractory acute myeloid leukemia . 2. To evaluate the effectiveness of targeted AML1-ETO neoantigen cytotoxic T cells (CTL),by the complete response rate(CRR) and overall survival (OS) followed.
Official title: A Clinical Study to Evaluate the Safety and Initial Efficacy of Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL) in the Treatment of Relapsed or Refractory t(8; 21) AML
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2024-02-01
Completion Date
2027-12-30
Last Updated
2025-08-28
Healthy Volunteers
No
Conditions
Interventions
targeted AML1-ETO neoantigen cytotoxic T cells (CTL)
After subject screening, peripheral blood mononuclear cell #PBMC# donors matching half or more of the subject's HLA matching will undergo blood collection to prepare neoantigen cytotoxic T cells. Neoantigen cytotoxic T cells preparation is expected to be 25-30 days after blood collection. In this study, the bridging therapy will be allowed before Chemotherapy preconditioning. Chemotherapy preconditioning will be performed before neoantigen cytotoxic T cells transfusion.
Cyclophosphamide injection
Cyclophosphamide injection will be performed in -10 to -8d before neoantigen cytotoxic T cells transfusion
Decitabine Injection
Decitabine Injection will be performed in -12 to -8d before neoantigen cytotoxic T cells transfusion
Liposome mitoxantrone
Liposome mitoxantrone will be performed in -9 to -8d before neoantigen cytotoxic T cells transfusion
Locations (1)
Shenzhen University General Hospital
Shenzhen, Guangdong, China