LB1908 / Legend Biotech - LARVOL DELTA

LB1908-1001: 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 (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Legend Biotech USA Inc | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Jul 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=34 | Terminated | Sponsor: Shanghai East Hospital | N=64 ➔ 34 | Trial completion date: Jun 2026 ➔ Jul 2023 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Jul 2023; Both the sponsors and collaborator are considering terminating the study

CAR T-Cell Therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

A phase 1, open-label, dose escalation and expansion, multicenter study of claudin 18.2-targeted chimeric antigen receptor T-cells in patients with unresectable, locally advanced, or metastatic gastric, gastroesophageal junction, esophageal, or pancreatic adenocarcinoma. (ASCO-GI 2023) - P1 | "Subjects may receive optional bridging therapy followed by lymphodepleting chemotherapy with fludarabine 30 mg/m2/day and cyclophosphamide 300 mg/m2/day for 3 days...Secondary and exploratory endpoints include: objective response rate, disease control rate, duration of response, progression-free survival, characterization of PK by CAR-positive T cell counts, CAR transgene level in blood, effusions, and target tissues, and evaluation of immunogenicity by presence of anti-LB1908 antibodies. Acknowledgments: This study is funded by Legend Biotech USA Inc. Clinical trial information: NCT05539430."

CAR T-Cell Therapy • Clinical • IO biomarker • Metastases • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CLDN18

LB1908-1001: 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 (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Legend Biotech USA Inc | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

LB1908-1001: 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 (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Legend Biotech USA Inc | Initiation date: Jan 2023 ➔ Apr 2023

CAR T-Cell Therapy • Metastases • Trial initiation date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

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 (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Legend Biotech USA Inc

CAR T-Cell Therapy • New P1 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Shanghai East Hospital | N=34 ➔ 64 | Trial completion date: Nov 2024 ➔ Jun 2026 | Trial primary completion date: Nov 2022 ➔ Dec 2023

CAR T-Cell Therapy • Enrollment change • Trial completion date • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • CLDN8

Legend Biotech Announces U.S. FDA Clearance of IND Application for Solid Tumor CAR-T, LB1908 for Relapsed or Refractory Gastric, Esophageal and Pancreatic Cancers (Businesswire) - "Legend Biotech Corporation...announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate LB1908 in a Phase 1 clinical trial in the United States....The Phase 1, first-in-human, open-label, multicenter clinical study seeks to characterize the safety and tolerability of LB1908, as well as determine the recommended dose for Phase 2 and evaluate preliminary efficacy."

IND • New P1 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Gastric Cancer (clinicaltrials.gov) - P1; N=34; Recruiting; Sponsor: Shanghai East Hospital; Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Clinical • Enrollment open • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2