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RECRUITING
NCT04146298
PHASE1/PHASE2

Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer

Sponsor: Changhai Hospital

View on ClinicalTrials.gov

Summary

This clinical trial will evaluate the safety and activity of mutant KRAS G12V-specific TCR transduced T cell therapy for advanced pancreatic cancer patients who express the KRAS G12V mutation and HLA-A\*11:01 allele. The theoretical basis of this study is that mutant KRAS antigen-specific TCR transduced autologous Tcells will target and kill HLA-matched mutant KRAS cancer cells but not normal cells.

Official title: Clinical Trial Evaluating the Safety and Activity of Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-10-21

Completion Date

2028-12

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide will be administered prior to cell infusion.

DRUG

Fludarabine

Fludarabine will be administered prior to cell infusion.

BIOLOGICAL

Mutant KRAS G12V-specific TCR transduced autologous T cells

After preconditioning regimen, T cells will be infused to the patient intravenously in the Patient Care Unit over approximately 30 to 50 minutes.

DRUG

Anti-PD-1 monoclonal antibody

During the treatment, anti-PD-1 monoclonal antibody will be administered if needed.

Locations (1)

Changhai Hospital

Shanghai, China