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A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors

NCT04467853 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-08-15

No results posted yet for this study

Summary

This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion 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 solid Tumors.

Conditions

  • Solid Tumors, Adult

Interventions

BIOLOGICAL

LCAR-C18S cells

Before treatment with LCAR-C18S cells, subjects will receive a conditioning regimen

Sponsors & Collaborators

  • Nanjing Legend Biotech Co.

    collaborator INDUSTRY

  • Shanghai East Hospital

    lead OTHER

Principal Investigators

  • Jin Li, MD, PhD · Shanghai East Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2023-07-17
Completion
2023-07-17

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04467853 on ClinicalTrials.gov