NCT06487377

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai Pudong Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients who sign the informed consent form will undergo screening based on inclusion/exclusion criteria. Eligible patients will be enrolled sequentially into dose group 1, dose group -1 or dose group 2, and dose group 3. The procedure of this study is as follows: (I) The collected peripheral blood mononuclear cells (PBMCs) will be transported to the production workshop for the preparation of IX001. After confirming that IX001 is proved qualified, the investigator will decide whether to start pre-conditioning 5 days before IX001 infusion. (II) TCR-T cells will be administered via intravenous infusion, and the cell infusion dose will be determined according to the requirements of dose escalation. (III) Following TCR-T cell infusion, recombinant human interleukin-2 (IL-2) will be continuously injected to assist TCR-T cell growth. (IV) After TCR-T cell infusion and IL-2 injection are completed, safety and efficacy follow-up visits will be conducted with the subjects until week 96 or until the subject prematurely withdraws from the study.

Conditions

• Pancreatic Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	IX001 TCR-T cells	IX001 TCR-T cell injection will be administered intravenously after lymphodepletion.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-03-01
• Completion: 2026-12-01
• First posted: 2024-07-05
• Last updated: 2024-07-05

Locations

1 site across 1 country: China