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 | Active, not recruiting | Sponsor: Legend Biotech USA Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

Phase 1 study of LB1908, an autologous claudin 18.2-targeted CAR-T cell product, in subjects with advanced gastroesophageal adenocarcinoma. (ASCO-GI 2026) - P1 | "Funded by Legend Biotech Clinical Trial Registration Number: NCT05539430 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

CAR T-Cell Therapy • Clinical • Metastases • P1 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Mechanistic data-informed multiscale quantitative systems pharmacology modeling framework enables the clinical translation and efficacy assessment of CAR-T therapy in solid tumors. (PubMed, J Immunother Cancer) - "Our translational QSP platform offers an innovative pathway to integrate multiscale knowledge and inform clinical decision-making of novel solid tumor-targeting CAR-T therapies."

Journal • Hematological Malignancies • Oncology • Solid Tumor • CLDN18

Preliminary results of a phase 1 study of LB1908, an autologous Claudin 18.2–targeted chimeric antigen receptor T-cell product, in patients with advanced gastroesophageal adenocarcinoma. (ASCO 2025) - P1 | "Bridging therapy was administered to all patients between apheresis and LB1908 infusion, and patients received standard lymphodepletion (LD) with cyclophosphamide/fludarabine... LB1908 demonstrates peripheral expansion and encouraging antitumor activity at the lowest dose tested, with a manageable safety profile. Implementation of a toxicity mitigation strategy ameliorated on-target gastric mucosal injury without compromising expansion kinetics or antitumor activity. Longer follow-up and data from patients treated with higher cell doses will be presented at the meeting."

CAR T-Cell Therapy • Clinical • IO biomarker • Metastases • P1 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • CLDN18

LB1908: Preliminary results of a Phase 1 study of a CLDN18.2-targeted CAR T-cell therapy show manageable safety and antitumor activity in patients with gastroesophageal cancers (Abstract #4022) (GlobeNewswire) - P1 | N=56 | NCT05539430 | Sponsor: Legend Biotech USA Inc | "Interim data from a Phase 1, first-in-human, open-label, multicenter study of LB1908, an autologous CAR-T targeting Claudin 18.2, were presented in patients with advanced gastric, gastroesophageal, and esophageal adenocarcinoma (GC/GEJC/EC) who are relapsed or refractory to one or more prior line of therapy and whose tumors express CLDN18.2 in 50% or more tumor cells....LB1908 demonstrated peripheral expansion and early signs of antitumor activity at the lowest dose tested, with a manageable safety profile. A toxicity mitigation strategy was implemented to address on-target gastric mucosal injury, which successfully reduced toxicity without compromising CAR-T expansion or antitumor activity. Additional data, including longer follow-up and outcomes from patients treated at higher dose levels, were also presented."

P1 data • Esophageal Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Legend Biotech Announces New Oncologic & Hematologic Therapeutic Developments at ASCO, EHA, and ASGCT (Legend Biotech) - "Legend Biotech Corporation...announced...that new data evaluating CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for patients living with multiple myeloma will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2025 European Hematology Association’s (EHA) Congress. Preliminary results from Phase 1 LB2102 and Phase 1 LB1908 ongoing dose-escalation studies in solid tumors, specifically lung and gastric cancers respectively, will also be featured in poster presentations at ASCO."

P1 data • P1/2 data • P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Multiple Myeloma • Small Cell Lung Cancer

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