NCT06675513

Autologous CAR-T Cells (WD-01) for Metastatic Colorectal Cancer

A Clinical Study on the Safety and Efficacy of GCC Targeting CAR-T Cells (WD-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 (WD-01) in the metastatic colorectal cancer.

Detailed description

The study will use autologous T cells collected from enrolled patient, modified using a 2nd generation CAR bearing lentiviral vector, 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 the autologous CAR-T cell treatments? • What are the dose-limiting toxicities (DLT) and treatment-emergent adverse events (TEAE)? • What is the treatment efficacy, as measured by objective response rate (ORR) and progression-free survival (PFS)? Investigators will assess whether the WD-01 CAR-T cells have good safety and efficacy in treating colorectal cancer. Participants will receive WD-01 GCC-CAR-T cells through a 3+3 dose escalation scheme. • Undergo chemotherapy pre-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	An armored GCC targeting WD-01 CAR-T to treat cancer patients Other Name:	Autologous WD-01 CAR-T therapy with Wondercel's "Warrior" armor strategy will be explored for its advantage over other armor platforms.

Timeline

• Start date: 2025-05-18
• Primary completion: 2027-12-30
• Completion: 2029-12-30
• First posted: 2024-11-05
• Last updated: 2025-05-20

Locations

2 sites across 1 country: China