RecruitingPhase 1NCT06898385

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


Sponsor

Sun Yat-sen University

Enrollment

9 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new immune cell therapy called IX001 TCR-T for people with advanced pancreatic cancer that carries a specific genetic mutation called KRAS G12V. KRAS mutations are among the most common — and previously untreatable — drivers of pancreatic cancer. This therapy involves taking a patient's own immune cells, engineering them to recognize and attack KRAS G12V-mutant cancer cells, and infusing them back into the body. This is a Phase 1 safety study. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with pancreatic ductal adenocarcinoma (confirmed by biopsy) - Your cancer carries the KRAS G12V mutation (confirmed by genetic testing) - You have unresectable (cannot be removed by surgery) or metastatic disease that has progressed after standard chemotherapy - You carry a specific immune marker (HLA type) that allows the therapy to work - Your general health and organ function meet the study requirements **You may NOT be eligible if...** - Your tumor does not carry the KRAS G12V mutation - You do not have the required HLA type for the therapy - You have active autoimmune disease or are on immunosuppressive medications - You have active brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIX001 TCR-T injection

IX001 TCR-T injection will be administered intravenously after lymphodepletion.

DRUGFludarabine

Fludarabine is used for lymphodepletion.

DRUGCyclophosphamide

Cyclophosphamide is used for lymphodepletion.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06898385


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