An Exploratory Clinical Study on the Safety and Efficacy of MSLN STAR-T Cells in Advanced Malignant Solid Tumors

Peking University0 sites12 target enrollmentApril 14, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Peking University
Enrollment: 12
Primary Endpoint: Percentage of adverse events
Status: Not Yet Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a single-center, single-arm, open-label Phase I study to evaluate the safety and efficacy of MSLN STAR-T cell immunotherapy in the treatment of advanced malignant solid tumors.

Detailed Description

This study is a single-center, dose-escalation, prospective, exploratory study to evaluate the safety and efficacy of MSLN STAR-T cells in patients with hepatocellular carcinoma. The study is divided into two phases: dose escalation and dose expansion. The total duration of each subject's participation in the study is expected to be 24 months, including the screening period, non-myeloablative chemotherapy pretreatment, cell infusion-observation period, and follow-up period.

Registry

clinicaltrials.gov

Start Date

April 14, 2022

End Date

February 1, 2026

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old, ≤ 70 years old, gender is not limited;
•Advanced malignant solid tumors confirmed by histology or cytology, including malignant mesothelioma (pleura, peritoneum, etc.), pancreatic cancer, ovarian cancer, intrahepatic bile duct cancer, lung cancer, gastric cancer, colorectal cancer, etc.;
•Patients with advanced malignant solid tumors who have relapsed after systemic therapy, or who cannot tolerate existing therapy, including but not limited to:
•Patients with malignant mesothelioma who have failed at least first-line therapy;
•Patients with pancreatic cancer who have failed at least first-line therapy;
•Patients with gastric cancer who have failed at least second-line therapy in the past;
•Patients with ovarian cancer who have previously failed at least second-line platinum-sensitive or platinum-resistant therapy;
•Patients with intrahepatic cholangiocarcinoma who have failed at least first-line therapy;
•Patients with advanced non-small cell lung cancer (non-squamous cell carcinoma): positive for EGFR, ALK, ROS1, MET and other driver genes, disease progression or intolerance after targeted therapy; negative for EGFR, ALK, ROS1, MET and other driver genes If the subject has disease progression or intolerance after receiving ≥ 1 line of therapy in the past;
•Patients with colorectal cancer who have failed at least second-line therapy.

Exclusion Criteria

•Those with uncontrolled active infection at the time of screening; those who meet one of the following:
•Hepatitis B surface antigen (HBsAg) positive and/or hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copy number greater than the detection limit, hepatitis C antibody (HCV-Ab) positive and HCV-RNA copy number greater than the lower limit of detection, human immunodeficiency virus (HIV) antibody positive, Treponema pallidum (TP-Ab) antibody positive;
•Patients with or with a history of central nervous system diseases, such as history of epilepsy, stroke, severe brain damage, aphasia, paralysis, etc.;
•Patients with active brain metastases but who do not need any radiation, surgery or steroid therapy to control metastatic symptoms 1 month before screening can be enrolled;
•Systemic lupus erythematosus, combined with active or uncontrolled autoimmune diseases (such as Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.);
•Are receiving therapeutic dose or systemic glucocorticoid therapy (prednisone ≥ 20 mg/day or equivalent dose of other corticosteroids);
•Toxicity or complications caused by previous interventions or treatments have not recovered to CTCAE v5.0 ≤ grade 2 or below (except for hair loss and abnormal values of laboratory tests judged by the investigator);
•Previously received other genetically modified T cell products (such as MSLN CAR-T or TCR-T cells), or treatment targeting MSLN;
•Patients who have received any of the following drugs or treatments within the specified time period prior to apheresis:
•Received any chemotherapy within 2 weeks or 5 half-lives, whichever is shorter, prior to apheresis;