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NOT YET RECRUITING
NCT05933668
PHASE1

Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Solid Tumor

Sponsor: Peking University

View on ClinicalTrials.gov

Summary

This study is a single center, open, single arm, dose increasing early clinical study. The purpose of this study is to evaluate the safety and efficacy of YK0901 immunotherapy in the treatment of patients with advanced solid tumor whose tumor antigen KRAS G12V expression is positive (HLA-A \* 11:01).

Official title: Phase I Clinical Study of YK0901 Injection for the Treatment of Advanced Solid Tumors With HLA-A * 11:01 Positive and KRAS G12V Mutation

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2023-07

Completion Date

2026-07

Last Updated

2023-07-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

YK0901 cells

On day 0, the TCR-T cells will be administered one time. Drug: Fludarabine + Cyclophosphamide+Oxaliplatin Fludarabine: 25mg/m²/day×3days Cyclophosphamide: 300mg/m²/day×3 days Oxaliplatin:100mg×1day Drug: IL-2 After 18-24 hours of infusion of YK0901 cells, the patients will be given a small dose of IL-2 subcutaneously, 500,000 IU/time, twice a day (interval 10-12 hours), for 14 days.

Locations (1)

Department of GI Oncology, Peking University Cancer Hospital

Beijing, China