NCT07266311

CAR-T for Claudin18.2 Positive Solid Tumors

Clinical Study on the Safety and Efficacy of CAR T-cell Therapy for Claudin18.2 Positive Advanced Solid Malignant Tumors

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Chengdu Ucello Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to learn if autologous claudin18.2-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat claudin18.2 positive solid tumors in adults. It will also learn about the safety and efficacy of the autologous claudin18.2 CAR-T cell product. The main questions it aims to answer are: 1. What CAR-T-related adverse events (AEs) occur within 3 months after the autologous CAR-T cell infusion? 2. What is the Objective Response Rate (ORR), Progression-free survival (PFS), duration of response (DOR), and overall survival (OS)? Participants will: 1. Undergo leukapheresis for collection of autologous T cells for CAR-T cell manufacturing. 2. May receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) for 3 consecutive days if clinically needed. 3. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. 4. Receive autologous CAR-T cells infusion on Day 0. 5. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 6. Visit the clinic at Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.

Conditions

• Claudin18.2 Positive Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	claudin18.2 CAR-T	injection of CAR T cells

Timeline

• Start date: 2025-12-15
• Primary completion: 2035-12-31
• Completion: 2037-12-31
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: China