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

Last updated: December 27, 2024
Sponsor: Peking University
Overall Status: Active - Recruiting

Phase

1

Condition

Gastric Ulcers

Gastrointestinal Diseases And Disorders

Stomach Cancer

Treatment

LCAR-G08 cells

Clinical Study ID

NCT06197178
LB2301-0001
  • Ages 18-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntary agreement to provide written informed consent.

  • Histologically confirmed metastatic colorectal cancers and other advancedgastrointestinal cancers (esophageal cancer, gastric cancer, pancreatic cancer, andsmall 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

Exclusion Criteria:

  • Previous CAR-T cell, T cell receptor-engineered (TCR) T cell, or therapeutic tumorvaccination treatment within the past 6 months; and the corresponding CAR-T, TCR-Tcells 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 patientparticipation in the study.Any condition that, in the investigator's judgment, willmake 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.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: LCAR-G08 cells
Phase: 1
Study Start date:
December 28, 2023
Estimated Completion Date:
March 31, 2028

Study 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.

Connect with a study center

  • Beijing Cancer Hospital & Institute

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Beijing GoBroad Hospital

    Beijing, Beijing 102200
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.