Pancreatic Cancer Clinical Trial
Official title:
Clinical Study of Chimeric Mesothelin Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Malignancies
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory
into patient autologous or donor-derived T cells may make the body build immune response to
kill cancer cells.
PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in
treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | November 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Chemotherapy refractory or relapsed mesothelin positive malignant mesothelioma,ovarian tumors,pancreatic cancer,triple negative breast cancer,endometrial cancer and other mesothelin positive tumor 2. Patients must be 18 years of age or older. 3. Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2. 4. Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters: Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter). Total bilirubin < 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m. 5. Seronegative for HIV antibody. 6. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. 7. Patients must be willing to practice birth control during and for four months following treatment. NOTE: women of child-bearing age must have evidence of negative pregnancy test. 8. Patients must be willing to sign an informed consent. Exclusion Criteria: 1. Patients with life expectancy less than 12 months will be excluded. 2. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded. 3. Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air. 4. Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded. 5. Pregnant and/or lactating women will be excluded. 6. Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors. 7. Patients with any type of primary immunodeficiencies will be excluded from the study. 8. Patients requiring corticosteroids (other than inhaled) will be excluded. 9. Patients with history of T cell tumors will be excluded. 10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | In vivo existence of CART-meso | 1 year | Yes | |
Primary | Occurrence of Study related adverse events | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical | Until week 24 | Yes |
Secondary | Anti-tumor responses to CART-meso cell infusions | up to 24 weeks | No |
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