TCR-T Cell Therapy on Advanced Pancreatic Cancer

Status Recruiting

Clinical Trial Summary

The primary aim of this study is to evaluate the efficacy of KRAS mutant antigen specific TCR-T cells in the treatment of patients with advanced pancreatic cancer. The secondary aim is to evaluate the pharmacokinetic/pharmacodynamic characteristics of TCR-T cell therapy in patients with advanced pancreatic cancer and the survival of TCR-T cells. The investigators will evaluate the changes of tumor microenvironment after treatment of advanced pancreatic cancer with KRAS mutant antigen specific TCR-T cells; Evaluating the correlation between cytokines and the occurrence of CRS and neurotoxicity

Clinical Trial Description

1.This study is a prospective and single arm clinical study. In this trial, 18 patients with advanced pancreatic cancer with KRAS G12V or G12D mutations and matching HLA-A*11:01 subtypes are recruited for autologous Tumor-T Cell Receptor (TCR) -Mediated T Cells therapy(TCR-T) therapy.Within 3 - 5 days after pretreatment, subjects will receive a single TCR-T infusion with an infusion dose of about 1 × 10⁹～1 × 10¹⁰.Once every 12 hours within 24 hours after TCR-T cell infusion, recombinant human interleukin-2 will be injected intravenously for 14 days . After 3 months of treatment, the patient's condition was evaluated. If the subject did not occur tumor progression and did not occur adverse events (AEs) of level 3 or higher, a second TCR-T cell reinfusion can be performed (informed consent form needs to be signed again). The study will evaluate the safety of TCR-T treatment by observing adverse events after cell therapy; evaluate the effectiveness of TCR-T compared to the results or historical data of the subject's own previous standard treatment regimen;and collect blood before and after cell infusion, measure the number and activity of TCR-T cells, and evaluate the pharmacokinetic (PK) characteristics of TCR-T. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05438667
Study type	Interventional
Source	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact	Meng Zhang, MD
Phone	+86 02034071785
Email	sysmhqkyxkek@mail.sysu.edu.cn
Status	Recruiting
Phase	Early Phase 1
Start date	June 7, 2022
Completion date	May 30, 2026

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