This is a prospective, single-arm, single-center, open-label, single-dose Phase 1 dose finding and extension study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive advanced gastric adenocarcinoma.

NCT04467853

Conditions

1. Gastric Cancer

Interventions

1. Biological: LCAR-C18S cells

MeSH:Stomach Neoplasms

HPO:Neoplasm of the stomach

A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of LCAR-C18S, an CAR-T Cell Therapy Targeting Claudin18.2 in Patients With Advanced Gastric Cancer. --- C18S ---

A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Gastric Cancer This is a prospective, single-arm, single-center, open-label, single-dose Phase 1 dose finding and extension study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive --- C18S ---

A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Gastric Cancer This is a prospective, single-arm, single-center, open-label, single-dose Phase 1 dose finding and extension study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive --- C18S --- --- C18S ---

Incidence of anti-LCAR-C18S antibody and positive sample titer. --- C18S ---

Venous blood samples will be collected to measure LCAR-C18S positive cell concentrations and the transgenic level of LCAR-C18S, at the time points when anti-LCAR-C18S antibody serum samples are evaluated. --- C18S ---

Venous blood samples will be collected to measure LCAR-C18S positive cell concentrations and the transgenic level of LCAR-C18S, at the time points when anti-LCAR-C18S antibody serum samples are evaluated. --- C18S --- --- C18S ---

Venous blood samples will be collected to measure LCAR-C18S positive cell concentrations and the transgenic level of LCAR-C18S, at the time points when anti-LCAR-C18S antibody serum samples are evaluated. --- C18S --- --- C18S --- --- C18S ---

Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LCAR-C18S cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1 only.. Duration of remission (DOR) after administration. --- C18S ---

Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-C18S to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first.. Overall Survival (OS) after administration. --- C18S ---

Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-C18S to death of the subject.. Disease control rate (DCR) after administration. --- C18S ---

Time to Response (TTR) is defined as the time from the date of first infusion of LCAR-C18S to the date of the first response evaluation of the subject who has met all criteria for PR or better.. Inclusion Criteria: 1. --- C18S ---