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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose. An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Time frame: 90 days post infusion
MTD/ RP2D regimen finding
Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
Time frame: 90 days post infusion
Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration
Venous blood samples will be collected for measurement of CAR-T positive cellular concentration
Time frame: 2 years post infusion
Disease control rate (DCR) after administration
Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease.
Time frame: 2 years post infusion
Objective Response Rate (ORR) after administration
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LCAR-M23 cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease as per RECIST 1.1 criteria only.
Time frame: 2 years post infusion
Time to Response (TTR) after administration
Time to Response (TTR) is defined as the time interval from the date of first infusion of LCAR-M23 cell formulation to the date of the first response evaluation of the subject who has met all criteria for PR or better.
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Time frame: 2 years post infusion
Duration of Response (DOR) after administration
Duration of Response (DOR) is defined as the time from the first documentation of response (PR or better) to the first documentation of disease progression evidence (as per RECIST 1.1 criteria) of the responders (who achieve PR or better response).
Time frame: 2 years post infusion
Progress Free Survival (PFS) after administration
Progression Free Survival (PFS) is defined as the time interval from the date of first infusion of LCAR-M23 cell formulation to the first documentation of disease progression (as per RECIST 1.1 criteria) or death (due to any cause), whichever occurs first.
Time frame: 2 years post infusion
Overall Survival (OS) after administration
Overall survival (OS) is defined as the time interval from the date of first infusion of LCAR-M23 cell formulation to death of the subject.
Time frame: 2 years post infusion