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A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer

NCT04562298 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-08-18

No results posted yet for this study

Summary

This study is a prospective, single-arm, open-label, single-dose dose finding and extension study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the LCAR-M23 CAR-T cell therapy in subjects with relapsed and refractory epithelial ovarian cancer after prior adequate standard of care.

Conditions

  • Epithelial Ovarian Cancer

Interventions

BIOLOGICAL

LCAR-M23 cells

Prior to infusion of LCAR-M23, subjects will receive a premedication regimen (intravenous infusion of cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 once daily for 3 days; fludarabine dose reduction to 25 mg/m2 and cyclophosphamide to 250 mg/m2 are allowed if the subject' s creatinine clearance is 50-70 mL/min/1.73 m2). A single dose, single Infusion of LCAR-M23 is scheduled 5 to 7 days after the initiation of the premedication regimen.

Sponsors & Collaborators

  • Nanjing Legend Biotech Co.

    collaborator INDUSTRY

  • East Clinical Center of Oncology

    collaborator UNKNOWN

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • Shanghai East Hospital

    lead OTHER

Principal Investigators

  • Ye Guo, PhD · East Clinical Center of Oncology

  • Yu Kang, PhD · Obstetrics & Gynecology Hospital of Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2022-06-07
Completion
2022-06-07

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 NCT04562298 on ClinicalTrials.gov