Clinical trialPhase 1Terminated
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
- Outcome
- Stopped earlyachieved the proof of concept (Other)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 28 December 2023
- Expected end
- 22 October 2025
- Enrollment
- 17 participants
- Sites
- 2
- Primary outcomes
- Dose-limiting toxicity (DLT) rate; Incidence, severity, and type of treatment-emergent adverse events (TEAEs); Recommended Phase 2 Dose (RP2D) regimen finding; Maximum concentration (Cmax); Time to Cmax (Tmax)
- Sponsor
- Other
- Results posted
- No
- Last update
- 6 February 2026
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Brief summary public domain (ClinicalTrials.gov)
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).
Detailed description public domain (ClinicalTrials.gov)
This is a phase 1, single-arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR- G08 in subjects with guanylyl cyclase C (GCC)-positive advanced gastrointestinal tumors. Subjects who meet the eligibility criteria will receive LCAR-G08 infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up.