NCT07342738

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

A Cliniacl Study of T Cell Receptor-engineered T-Cell (TCR-T) Injection in Patients With Advanced Solid Tumors Induced by Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations.

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, Multicenter, open-label clinical study aimed at evaluating the safety and efficacy of TCR-T injection in patients with advanced solid tumors induced by KRAS mutations.

Detailed description

This study is planned to enroll patients with advanced solid tumors who have KRAS G12V or G12D mutations and matching Human Leukocyte Antigen(HLA)-A\*11:01 or HLA-C\*01:02 subtypes. The study consists of screening period, leukapheresis period, lymphodepletion period, treatment period, observation period and follow-up period. The patients were treated lymphodepletion treatment with cyclophosphamide and fludarabine and than infused TCR-T. All subjects who have received TCR-T injection will be followed for safety and efficacy up to 1 years.

Conditions

• KRAS G12V
• KRAS G12D
• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	TCR-T cells	TCR-T cell injection will be administered intravenously after lymphodepletion.
DRUG	Fludarabine	Fludarabine is used for lymphodepletion.
DRUG	Cyclophosphamide	Cyclophosphamide is used for lymphodepletion.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-02-01
• Completion: 2029-02-01
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: China