Viewing Study NCT04513431



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Last Modification Date: 2024-10-26 @ 1:42 PM
Study NCT ID: NCT04513431
Status: UNKNOWN
Last Update Posted: 2020-08-14
First Post: 2020-07-31

Brief Title: A Clinical Research of CAR T Cells Targeting CEA Positive Colorectal Cancer CRC
Sponsor: Ruijin Hospital
Organization: Ruijin Hospital

Study Overview

Official Title: A Study Evaluating the Safety and Preliminary Efficacy of Anti-CEA CAR-T Cells for the Prevention of Postoperative Recurrence and Metastasis of Stage III Colorectal Cancer or Liver Metastasis of Colorectal Cancer
Status: UNKNOWN
Status Verified Date: 2020-08
Last Known Status: NOT_YET_RECRUITING
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: CRC
Brief Summary: The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused
Detailed Description: Chimeric antigen receptor CAR-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 CD19 positive B cell malignancies But it has few studies in solid tumors The carcino-embryonic antigenCEA is widely expressed in cancers like gastric cancer lung cancer pancreatic cancer breast cancer and colorectal cancer To confirm if CAR T cells still function in solid tumors we have developed anti-CEA CAR-modified T cells Preclinical studies have demonstrated effective killing of CEA target cells In this study the CEA CARs will be evaluated in CEA positive gastric cancer The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects In addition tumor targeting and disease status after treatment will also be evaluated

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