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A Phase 1 Study of LCAR-C182A Cells in the Treatment of Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma

NCT03890198 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-07-02

No results posted yet for this study

Summary

This is an open label, single center, single arm phase 1 study to evaluate the safety , tolerability, pharmacokinetics and efficacy and immunogenicity of LCAR-C182A cells targeting Claudin18.2 in the treatment of patients with advanced gastric cancer and Pancreatic Ductal Adenocarcinoma.

Conditions

Interventions

BIOLOGICAL

LCAR-C182A cells

Patients receive fludarabine (3×300 mg/ m\^2) and cyclophosphamide (3×30 mg/m\^2) IV on days -5 to-3, and then Patients receive CAR-T cells. PS：The specific dose of fludarabine and cyclophosphamide is adjusted according to the individual condition of the subject and the judgment of the investigator.

Sponsors & Collaborators

  • Nanjing Legend Biotech Co.

    collaborator INDUSTRY

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Enxiao Li, MD,PhD · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2020-03-06
Completion
2020-03-06

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03890198 on ClinicalTrials.gov