A Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting Mesothelin in Patients With Recurred or Metastatic Malignant Tumors

China Meitan General Hospital1 site in 1 country20 target enrollmentAugust 2016

ConditionsMesothelin Positive Tumors

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Mesothelin Positive Tumors
Sponsor: China Meitan General Hospital
Enrollment: 20
Locations: 1
Primary Endpoint: safety of infusion of autologous anti-mesothelin CAR T cells as assessed by the incidents of treatment related adverse events per NCI CTCAE V4.0
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or metastatic malignant tumors.

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

August 2019

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

China Meitan General Hospital

Responsible Party

Principal Investigator

Jinwen Sun

director of Department of General Surgery and Surgical Oncology

China Meitan General Hospital

Eligibility Criteria

Inclusion Criteria

•patients with mesothelin positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic adenocarcinoma, ovarian cancer, or pleural mesothelioma.
•relapsed or metastatic after standard treatment
•measurable tumors by RECIST1.1 standard
•patients are 18 to 70 years old.
•life expectancy \> 3months.
•satisfactory major organ functions: adequate heart function with LVEF≥50%; no obvious abnormities in ECG; pulse oximetry ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl .
•Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10\^9/L, PLT ≥ 50×10\^9/L.
•women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.

Exclusion Criteria

•patients with a prior history of autoimmune disease or other diseases who need long-term use of systemic hormone drug or immunosuppressive therapy
•active infection.
•HIV positive.
•active hepatitis B virus infection or hepatitis C virus infection.
•currently enrolled in other study.
•patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
•patients who have allergic disease, or are allergic to T cell products or other biological agents used in the study.
•patients whose tumors have metastasized to bone marrow, or have clinical signs of bone metastasis, such as bone and joint pain .
•patients who have brain metastasis or signs of brain metastasis, such as loss of self-consciousness.