NCT06653010

Universal CAR-T Cells (REVO-UWD-01) for Metastatic Colorectal Cancer

A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells (REVO-UWD-01) for Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Wondercel Biotech (ShenZhen) · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (REVO-UWD-01) in the metastatic colorectal cancer. It also aims to explore the feasibility of using a novel universal CAR-T cell platform.

Detailed description

The study will use T cells from healthy donors, modified using a novel universal CAR-T technology, to treat metastatic colorectal cancer patients. The antigen-binding site of the CAR molecule recognizes GCC as the target. The main questions it aims to answer are: * What is the maximum tolerated dose (MTD) of GCC-CAR-T therapy in universal CAR-T cell treatments? * What are the dose-limiting toxicities (DLT) and treatment-emergent adverse events (TEAE)? * What is the treatment\'s efficacy, as measured by objective response rate (ORR) and progression-free survival (PFS)? Researchers will assess whether universal CAR-T cells have good safety and efficacy in treating colorectal cancer, while improving accessibility and lowering treatment costs. Participants will: * Receive universal GCC-CAR-T cells through a 3+3 dose escalation scheme. * Undergo chemotherapy conditioning before CAR-T infusion. * Be monitored for adverse events, immune response, and disease progression. The study will collect data on both short-term outcomes (within the first few months post-treatment) and long-term safety and efficacy.

Conditions

• CRC (Colorectal Cancer)
• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Universal CAR-T cells injection for treating mCRC	A novel universal CAR-T platform to treat cancer patients

Timeline

• Start date: 2024-10-23
• Primary completion: 2027-10-20
• Completion: 2027-12-30
• First posted: 2024-10-22
• Last updated: 2026-01-16

Locations

2 sites across 1 country: China