March 2023:
Brief Summary:
The goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen receptors CAR T-cell therapy for relapsed and refractory epithelial ovarian cancer.
Detailed Description:
Primary Objectives
To determine the feasibility ad safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer.
Secondary Objectives
To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer.
To determine in vivo dynamics and persistency of anti- MESO CAR-T cells.
Study design
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of MESO-CAR T Cells Therapy for Relapsed and Refractory Epithelial Ovarian Cancer
Estimated Study Start Date : April 20, 2019
Estimated Primary Completion Date : April 20, 2022
Estimated Study Completion Date : April 20, 2023
Criteria
Inclusion Criteria:
18 to 70 Years Old, female; Expected survival > 12 weeks; Clinical performance status of ECOG score 0-2; Patients who have previously been treated with second- line or more lines of standard treatment are not effective (No remission or recurrence after remission); At least one measurable tumor foci according to RECIST standard 1.1 ; Positive Mesothelin expression in tumor tissues; Creatinine ≤ 1.5×ULN; ALT and AST ≤ 3×ULN; Total bilirubin ≤ 2×ULN; Hemoglobin≥90g/L; Absolute counting of neutrophils≥1000uL ; Absolute counting of lymphocytes>0.7×10^9/L; Counting of Platelet≥75000/uL; The venous access required for collection can be established without contraindications for leukocyte collection; Able to understand and sign the Informed Consent Document.
Exclusion Criteria:
Accompanied by other uncontrolled malignant tumors; Active hepatitis B, hepatitis C, syphilis, HIV infection; Suffering severe cardiovascular or respiratory disease; Any other diseases could affect the outcome of this trial; Any affairs could affect the safety of the subjects or outcome of this trial; Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment; There are active or uncontrollable infections (except simple urinary tract infections or upper respiratory tract infections) that require systemic therapy 14 days or 14 days prior to assignment; Patients who are accounted by researchers to be not appropriate for this test; Received CAR-T treatment or other gene therapies before assignment; Subject suffering disease affects the understanding of informed consent or comply with study protocol.
China has taken lead in conducting CAR T-Cell therapy clinical trials. Check the list of hospitals doing CAR T-Cell therapy in China.
