A Study of LCAR-G08 in Subjects With Advanced Gastrointestinal Tumors Expressing Guanylyl Cyclase C (GCC)

Advanced Gastrointestinal Tumors Clinical Trial

Official title: A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of (LCAR)-G08, a Chimeric Antigen Receptor (CAR)-T Cell Therapy Targeting Guanylyl Cyclase C (GCC) in Subjects With Advanced Gastrointestinal Tumors

Status Recruiting

Clinical Trial Summary

This is a phase 1, single-arm, open-label, dose escalation and expansion study of LCAR-G08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase C (GCC).

Clinical Trial Description

This is a phase 1, single-arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR- G08 in subjects with guanylyl cyclase C (GCC)-positive advanced gastrointestinal tumors. Subjects who meet the eligibility criteria will receive LCAR-G08 infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up. ;

Related Conditions & MeSH terms

• Advanced Gastrointestinal Tumors
• Digestive System Neoplasms
• Gastrointestinal Neoplasms

• NCT number: NCT06197178
• Study type: Interventional
• Source: Peking University
• Contact: Lin Shen
• Phone: 010-88196561
• Email: Doctorshenlin@sina.com
• Status: Recruiting
• Phase: Phase 1
• Start date: January 2024
• Completion date: March 2028