Clinical trial NCT02930993: Anti-mesothelin CAR T Cells for Patients With Recurrent or Metastatic Malignant Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Mesothelin Positive Tumors
Lead sponsor: China Meitan General Hospital
Sponsor class: OTHER
Collaborators: name: Marino Biotechnology Co., Ltd.
First posted: 2016-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. patients with mesothelin positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic adenocarcinoma, ovarian cancer, or pleural mesothelioma.
2. relapsed or metastatic after standard treatment
3. measurable tumors by RECIST1.1 standard
4. patients are 18 to 70 years old.
5. life expectancy \> 3months.
6. KPS ≥70.
7. 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 .
8. Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10\^9/L, PLT ≥ 50×10\^9/L.
9. 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:

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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: treatment response rate of anti-mesothelin CAR T cells
timeFrame: 4 weeks
measure: progression free survival
timeFrame: 6 months
measure: overall survival
timeFrame: 2 years
measure: proliferation of anti-mesothelin CAR T cells in patients
timeFrame: 6 months
measure: activation of anti-mesothelin CAR T cells in patients
timeFrame: 6 months
measure: persistence of anti-mesothelin CAR T cells in patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Meitan General Hospital
Study officials:
affiliation: China Meitan General Hospital
name: Jinwen Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: