NCT06084286

Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors

A Phase I, Open-label, Single-arm, Dose-escalation and Expansion Study of Specific Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Claudin18.2(CLDN18.2) is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in many solid tumors, especially in gastric cancer and pancreatic cancer. The CLDN18.2/PD-L1 dual-targeting CAR-T will be investigated in patients with CLDN18.2-positive advance solid tumors.

Detailed description

In this study, the CLDN18.2/PD-L1 dual-targeting CAR-T cells will be injected intravenously to patients with CLDN18.2-positive advanced solid tumors, such as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and pancreatic adenocarcinoma, who had nearly no response to standard treatment. The safety and effectiveness will be evaluated. The safety evaluation standard refers to the standard of CTCAE 5.0. The evaluation standard of effectiveness refers to the evaluation standard of solid tumor curative effect RECIST 1.1 to evaluate the curative effect. There are two phases of this study. The first is dose escalation phase, and 9 patients with CLDN18.2-positive advanced solid tumors are planned to be enrolled. The second is dose expansion phase. The curative effect has been observed in the first phase, and after the DLT observation period of the related dose group finished, the PI will decide whether to conduct the dose expansion research finally. It is planned to enroll 20 patients in dose expansion phase.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Dual-targeting CLDN18.2 and PD-L1 CAR-T cells	The trial consists of a traditional '3 + 3' pattern dose-escalation phase and a dose-expansion phase.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-10-30
• Completion: 2026-10-30
• First posted: 2023-10-16
• Last updated: 2024-11-19

Locations

1 site across 1 country: China