NCT05539430

Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma

A Phase 1, Open-Label, Dose Escalation and Expansion, Multicenter Study of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Legend Biotech USA Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, Open-Label, Dose Escalation and Expansion, Multicenter Study of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects with Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma

Detailed description

This is a Phase 1, open label, dose escalation, multicenter study to evaluate Claudin 18.2-targeting CAR-T cells (LB1908) in adult subjects with unresectable, locally advanced or metastatic gastric, GEJ, esophageal, or pancreatic adenocarcinoma. Patients will be confirmed to have sufficient expression of Claudin 18.2 as part of a prescreening. The study comprises a dose-escalation component (Part A) and a dose-expansion component (Part B). In part A, patients with gastric, GEJ, or esophageal adenocarcinoma will be treated with LB1908 at protocol-defined dose level, with escalation to higher doses in subsequent patients guided by evaluation of protocol-defined dose limiting toxicities (DLTs). Part A will identify the recommended dose for expansion (RDE) to be tested in part B in several cohorts: * Monotherapy regimen (MR) cohorts: treating second or later line gastric, GEJ, and esophageal adenocarcinoma or pancreatic adenocarcinoma patients as standalone treatment. * Consolidation regimen (CR) cohorts: treating frontline gastric, GEJ, and esophageal adenocarcinoma or pancreatic adenocarcinoma patients who have achieved disease control with standard of care chemotherapy. Part B will aim to identify the recommended dose for phase 2 (RP2D)and evaluate preliminary efficacy in these different treatment settings and patient populations.

Conditions

• Gastric Cancer
• Gastroesophageal-junction Cancer
• Esophageal Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	LB1908	Claudin 18.2-Targeted autologous Chimeric Antigen Receptor T-cells

Timeline

• Start date: 2023-04-18
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-09-14
• Last updated: 2025-12-12

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study