Anti-mesothelin CAR T Cells for Patients With Recurrent or Metastatic Malignant Tumors
- Conditions
- Mesothelin Positive Tumors
- Interventions
- Biological: anti-mesothelin CAR T cells
- Registration Number
- NCT02930993
- Lead Sponsor
- China Meitan General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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.
- KPS ≥70.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description anti-mesothelin CAR T cells anti-mesothelin CAR T cells Dose escalation study aimed to assess the safety and efficacy of anti-mesothelin CAR T cells. CAR T dosage ranging from 5×10\^4 /kg to 1×10\^7 /kg will be tested .
- Primary Outcome Measures
Name Time Method 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 2 years incidents of treatment related adverse events per NCI CTCAE V4.0
- Secondary Outcome Measures
Name Time Method activation of anti-mesothelin CAR T cells in patients 6 months measured by blood cytokine levels after CAR T cell infusion
persistence of anti-mesothelin CAR T cells in patients 1 year measured by quantitative PCR and flow cytometry
treatment response rate of anti-mesothelin CAR T cells 4 weeks Defined as the overall response rate (ORR), the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on the response evaluation criteria in solid tumor version 1.1 (RECIST1.1).
overall survival 2 years proliferation of anti-mesothelin CAR T cells in patients 6 months measured by quantitative PCR and flow cytometry
progression free survival 6 months
Trial Locations
- Locations (1)
China Meitan General Hospital
🇨🇳Beijing, China