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

Peking University

Status and phase

Enrolling

Phase 1

Conditions

Advanced Gastrointestinal Tumors

Treatments

Biological: LCAR-G08 cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06197178

LB2301-0001

Details and patient eligibility

About

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).

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.