Ignite Creation Date:
2024-07-17 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487377
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-07
Brief Title:
IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations
Sponsor:
Shanghai Pudong Hospital
Organization:
Shanghai Pudong Hospital
Study Overview
Official Title:
A Clinical Study of IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 33 dose escalation design
Detailed Description:
Patients who sign the informed consent form will undergo screening based on inclusionexclusion 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None