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

  • STATUS
    Recruiting
  • End date
    Mar 15, 2028
  • participants needed
    42
  • sponsor
    Peking University
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Updated on 16 January 2024
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Summary

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).1

Description

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.

Details
Condition Advanced Gastrointestinal Tumors
Age 18years - 70years
Treatment LCAR-G08 cells
Clinical Study IdentifierNCT06197178
SponsorPeking University
Last Modified on16 January 2024

Eligibility

 Yes No Not Sure

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
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