A Study of LCAR-G08 in Subjects With Advanced Gastrointestinal Tumors Expressing Guanylyl Cyclase C (GCC)

Launched by PEKING UNIVERSITY · Jan 7, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called LCAR-G08 for adults with advanced gastrointestinal tumors, specifically those that show a protein called guanylyl cyclase C (GCC) on their cancer cells. The trial is in its early phase, meaning researchers are testing the safety and effectiveness of this treatment. It’s currently open for enrollment, and they are looking for participants aged 18 to 70 who have specific types of cancers, including metastatic colorectal, esophageal, gastric, pancreatic, and small bowel cancers. To be eligible, patients need to have confirmed GCC-positive tumors and at least one measurable tumor that doctors can track during the study.

Participants in this trial can expect to receive the LCAR-G08 treatment, and they will be closely monitored for any side effects and how well the treatment is working. It's important to note that this study cannot accept individuals who have recently undergone certain types of cancer treatments or have specific health conditions, such as brain metastases or serious infections. If you're considering participating, you'll need to provide written consent, and your doctor can help determine if you meet the necessary criteria.

Gender

ALL

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.