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

PHASE1TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 21, 2020

Primary Completion Date

June 7, 2022

Study Completion Date

June 7, 2022

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.

Trial Locations (1)

Unknown

Shanghai East Hospital, Shanghai

Sponsors
All Listed Sponsors
collaborator

Nanjing Legend Biotech Co.

INDUSTRY

collaborator

East Clinical Center of Oncology

UNKNOWN

collaborator

Anhui Provincial Hospital

OTHER_GOV

lead

Shanghai East Hospital

OTHER

NCT04562298 - 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 | Biotech Hunter | Biotech Hunter