A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of (LCAR)-G08, a Chimeric Antigen Receptor (CAR)-T Cell Therapy Targeting Guanylyl Cyclase C (GCC) in Subjects With Advanced Gastrointestinal Tumors

LB2301-0001

This is a phase 1, single-arm, open-label, dose escalation and expansion study of LCAR-G08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase C (GCC).

2024-01-01

2025-11-01

2028-03-01

Recruiting

Early phase I

42

Inclusion Criteria: * Voluntary agreement to provide written informed consent. * Histologically confirmed metastatic colorectal cancers and other advanced gastrointestinal cancers (esophageal cancer, gastric cancer, pancreatic cancer, and small bowel cancer). * Aged 18 to 70 years, either sex. * GCC immunohistochemistry (IHC) staining is positive. * At least one measurable tumor lesion according to RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Expected survival ≥ 3 months. * Clinical laboratory values meet screening visit criteria. Exclusion Criteria: * Previous CAR-T cell, T cell receptor-engineered (TCR) T cell, or therapeutic tumor vaccination treatment within the past 6 months; and the corresponding CAR-T, TCR-T cells can still be detected. * Ever received any treatment targeting GCC. * Prior antitumor therapy with insufficient washout period. * Brain metastases. * Pregnant or lactating women. * Hepatitis C virus (HCV) antibody-positive or human immunodeficiency virus (HIV) antibody-positive, active syphilis, Epstein-Barr virus (EBV) infected. * Severe underlying disease. * Presence of other serious pre-existing medical conditions that may limit patient participation in the study.Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 42, 'type': 'ESTIMATED'}}

2024-01-09