Official Title
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
Phase
Phase 1Lead Sponsor
Huazhong University of Science and TechnologyStudy Type
InterventionalStatus
TerminatedIndication/Condition
Epithelial Ovarian CancerIntervention/Treatment
LCAR-M23 cellsStudy Participants
15This 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.
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.
Inclusion Criteria: The subjects have been fully informed of the possible risks and benefits of participating in this study and have voluntarily signed the informed consent form (ICF) Age: 18-70 years (including 18 and 70 years) Female subjects with histologically or cytologically confirmed advanced epithelial ovarian cancer including fallopian tube and primary peritoneal cancers Mesothelin (MSLN) positive Prior adequate standard of care, treatment failure or intolerance. Imaging shows an evaluable tumor lesion ECOG 0-1 Expected survival ≥ 3 months Exclusion Criteria: Patients who have received the following anti-tumor treatments prior to apheresis: Cytotoxic therapy within 14 days Small molecule targeted therapy within 14 days or at least 5 half-lives, whichever is shorter Therapy with monoclonal antibody within 21 days Immunomodulatory therapy within 7 days Radiotherapy within 14 days and endocrine therapy within 14 days (including tamoxifen, aromatase inhibitor, high-potency progesterone and gonadotropin-releasing hormone analogue, etc.) Previously treated with CAR-T/TCR-T cell therapy against any target or other cell therapies or therapeutic tumor vaccine Previously treated with any MSLN-targeted therapy Brain metastases with central nervous system symptoms Pregnant or lactating women Any condition in which, in the opinion of the investigator, the subject is ineligible for participation in the study
