RecruitingPhase 1NCT06487377

IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations

A Clinical Study of IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations


Sponsor

Shanghai Pudong Hospital

Enrollment

12 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, single-center, open-label clinical study aimed at evaluating the safety and efficacy of IX001 TCR-T (T cell receptor-engineered T-Cell) injection in patients with advanced pancreatic cancer and colorectal cancer induced by KRAS (Kirsten Rat Sarcoma Viral Oncogene) mutations. A total of 6-18 evaluable patients are planned to be enrolled. The study will include 4 dose groups, using a '3+3' dose escalation design.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of immune cell therapy called IX001 TCR-T — immune cells engineered to recognize and attack cancer cells with specific KRAS mutations — in adults with advanced pancreatic cancer or colorectal cancer whose tumors carry one of these specific genetic changes. **You may be eligible if...** - You are between 18 and 70 years old - You have advanced pancreatic cancer or colorectal cancer confirmed by tissue testing - Your cancer has failed at least two standard treatment regimens - Your tumor or blood tests show a KRAS-G12V or G12D mutation and you carry specific immune system markers (HLA subtypes) - You have at least one measurable tumor and adequate organ function - You have a good performance status (ECOG 0-2) and a life expectancy of at least 3 months **You may NOT be eligible if...** - Your tumor does not have the required KRAS mutation or HLA markers - Your cancer has not failed two prior treatment regimens - You have severe organ dysfunction or very low blood counts - 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 cells

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


Locations(1)

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, China

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NCT06487377


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