Treatment for advanced gastrointestinal tumors using LCAR-G08

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

This study is testing a new cell-based therapy called LCAR-G08 to see if it can safely help adults with advanced gastrointestinal tumors that have a specific marker.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking University (other)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT06197178 on ClinicalTrials.gov

What this trial studies

This phase 1, single-arm, open-label study evaluates the safety and efficacy of LCAR-G08, a cell-based therapy, in adults with advanced gastrointestinal tumors that express guanylyl cyclase C (GCC). Participants will undergo a series of phases including screening, pre-treatment with lymphodepleting chemotherapy, and LCAR-G08 infusion. The study aims to assess the pharmacokinetics and anti-tumor effects of the treatment. The goal is to determine the optimal dosage and monitor the treatment's safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed metastatic colorectal or other advanced gastrointestinal cancers that are GCC-positive.

Not a fit: Patients who have previously received CAR-T cell therapy or treatments targeting GCC may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastrointestinal tumors expressing GCC.

How similar studies have performed: While this approach is novel in targeting GCC-positive tumors, similar CAR-T cell therapies have shown promise in other cancer types.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing and 1 other locations

• Beijing Cancer Hospital & Institute — Beijing, Beijing, China (RECRUITING)
• Beijing GoBroad Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Lin Shen — Peking University Cancer Hospital & Institute
• Study coordinator: Lin Shen

Conditions: Advanced Gastrointestinal Tumors