NCT06767046

KRAS-Specific Autologous TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors

An Exploratory Study to Evaluate the Safety and Preliminary Efficacy of KRAS-Specific Autologous TCR-T Cells in Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Corregene Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, single-arm, dose-escalation study aimed at evaluating the safety and preliminary efficacy of KRAS-specific autologous TCR-T cells in patients with advanced solid tumors harboring KRAS G12V mutation.

Detailed description

T cell receptor-gene engineered T cells (TCR-T) therapy is a highly targeted form of cellular immunotherapy. It is safer than Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) and is currently a hot topic in immunotherapy. In the case of advanced pancreatic cancer with KRAS mutations, the infusion of TCR-T cells has achieved good efficacy and safety, further suggesting the promising prospects of TCR-T cell immunotherapy for advanced solid tumors with KRAS G12V mutation. It is planned to enroll 9 - 18 patients with advanced solid tumors who have KRAS G12V mutation and HLA-A\*11:01 genotype, and have failed standard treatments. A single-center, open-label, single-arm study design will be adopted. The KRAS-specific autologous TCR-T cell injection will be used to treat these patients. The primary endpoint is safety, and the secondary endpoints include efficacy, cell activity, etc. It is planned to select three dose groups with 5×10⁹, 1×10¹⁰, and 2×10¹⁰ TCR-T cells respectively, and conduct dose escalation using a 3 + 3 study design. The key steps involved in the study are the preparation and quality control of TCR-T cells, lymphocyte depletion (lymphodepletion), and the infusion of autologous TCR-T cell injection. Record and promptly handle specific adverse reactions of cellular immunotherapy, such as cytokine release syndrome (CRS), various other adverse events, off-target effects of TCR-T, and adverse events related to tumorigenic potential, etc., to obtain safety data. It is hoped that the results of this study will bring a new future for patients with advanced solid tumors with specific KRAS mutations.

Conditions

• Colorectal
• Pancreatic
• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	KRAS-specific Autologous TCR-T cell injection	Drug1 : Fludarabine + Cyclophosphamide Drug2 :Interleukin 2 Drug3 :KRAS-specific Autologous TCR-T cell injection

Timeline

• Start date: 2025-02-18
• Primary completion: 2028-11-30
• Completion: 2028-12-31
• First posted: 2025-01-09
• Last updated: 2026-03-25

Locations

1 site across 1 country: China