NCT06898385

A Phase I Clinical Study of IX001 TCR-T Injection in the Treatment of Advanced Pancreatic Cancer Patients With KRAS G12V Mutation

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (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, open-label clinical study to evaluate the safety, tolerability and preliminary efficacy of IX001 TCR-T injection in advanced pancreatic cancer patients with KRAS G12V mutation.

Detailed description

This study will enroll participants with advanced pancreatic cancer patients with KRAS G12V mutation. The study consists of screening period, leukapheresis period, lymphodepletion period, treatment period, observation period and follow-up period. A total of 9-12 evaluable patients are planned to be recruited. The study is planned to be conducted using the "3 + 3" dose escalation design in two dose groups, and a single dose of the study drug will be administered at the dose levels of 3 × 10\^9 ± 30% cells and 1 × 10\^10 ± 30% cells. Subjects will be enrolled sequentially and treated by IX001 TCR-T injection at the corresponding planned dose level. All subjects who have received IX001 TCR-T injection will be followed for safety and efficacy up to 2 years.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	IX001 TCR-T injection	IX001 TCR-T injection will be administered intravenously after lymphodepletion.
DRUG	Fludarabine	Fludarabine is used for lymphodepletion.
DRUG	Cyclophosphamide	Cyclophosphamide is used for lymphodepletion.

Timeline

• Start date: 2025-03-27
• Primary completion: 2027-03-27
• Completion: 2027-09-27
• First posted: 2025-03-27
• Last updated: 2026-01-08

Locations

1 site across 1 country: China