NCT07394205

Clinical Study of CBG131 CAR-T Cell Injection for the Treatment of CLDN18.2-Positive Advanced Gastric and Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if CBG131 works to treat advanced gastric cancer or pancreatic cancer in adults whose tumors are CLDN18.2-positive. It will also learn about the safety of CBG131 and find the best dose to use. The main questions it aims to answer are: Is CBG131 safe, and what medical problems do participants have when receiving it? Does CBG131 shrink tumors in participants with CLDN18.2-positive cancers? How long do the CAR-T cells stay and work in the body? Researchers will test different doses of CBG131 to see which dose is safest and most effective. This is an early-stage trial, so there is no placebo group-everyone who joins will receive the actual treatment. Participants will: Have their blood cells collected through a procedure called leukapheresis (so the CAR-T cells can be made). Receive chemotherapy for 3 days to prepare their body for the CAR-T cells Get a single infusion of CBG131 CAR-T cells through an IV. Visit the clinic frequently for the first month, then regularly for 2 years for checkups, blood tests, and tumor assessments. Keep track of their symptoms and any side effects they experience.

Conditions

• Advanced Gastric and Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	CBG131 CAR-T Cell Infusion	This Phase I trial follows a conventional 3 + 3 dose-escalation schema. Cohorts: (1) DL1 (de-escalation cohort): 0.5×10⁸ CAR⁺ T cells; (2) DL1 (starting dose cohort): 1×10⁸ CAR⁺ T cells; (3) DL2: 2×10⁸ CAR⁺ T cells. Three subjects are enrolled in each cohort. Absence of Dose-Limiting Toxicity (DLT) permits dose escalation; one DLT triggers expansion of the cohort by three additional subjects at the same dose. If, during expansion, one or more additional DLTs occur: (1) in the DL1 (starting dose cohort), dose escalation is suspended and de-escalation is considered; (2) in DL2 or higher cohorts, dose escalation stops and the preceding dose is declared the Maximum Tolerated Dose (MTD). If no further DLTs appear, dose escalation proceeds.

Timeline

• Start date: 2026-09-30
• Primary completion: 2027-03-31
• Completion: 2030-01-31
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: China