Clinical trial · Interventional
A Study of LCAR-G08 in Subjects With Advanced Gastrointestinal Tumors Expressing Guanylyl Cyclase C (GCC)
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
NCT06197178CI-TRIAL-00102675terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): achieved the proof of concept
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastrointestinal Tumors | Digestive System Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LCAR-G08 cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chimeric Antigen Receptor T cell LCAR-G08 Cells
- description
- Each subject will receive LCAR-G08 Cells
- interventionNames
- Biological: LCAR-G08 cells
Primary outcomes (7)
- measure
- Dose-limiting toxicity (DLT) rate
- timeFrame
- Minimum 2 years after LCAR-G08 infusion (Day 1)
- description
- Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
- measure
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
- timeFrame
- Minimum 2 years after LCAR-G08 infusion (Day 1)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.