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ENROLLING BY INVITATION
NCT06499025
EARLY_PHASE1

Treatment of Relapsed or Refractory t(8; 21) AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL)

Sponsor: BGI, China

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

DRUG

Cyclophosphamide injection

Cyclophosphamide injection will be performed in -10 to -8d before neoantigen cytotoxic T cells transfusion

DRUG

Decitabine Injection

Decitabine Injection will be performed in -12 to -8d before neoantigen cytotoxic T cells transfusion

DRUG

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