Advanced Malignant Tumor
Conditions
Interventions
the treatment group:MAGE-3 antigen/mutation specific antigen specific T cell targeted immunotherapy
Sponsors
Oncology Department of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 to 75 years old; 2. Histologic or cytologic confirmation of advanced refractory solid tumors with no available curative treatment options; 3. At least one measurable disease: diameter =20mm or spiral computed tomography(CT)=10mm; and can providing with tumor specimen (for testing the expression of PD -L1 and the infiltrating lymphocytes); 4. Must be human leukocyte antigen (HLA)-A2/A24/A11 positive; 5. Eastern Cooperative Oncology Group(ECOG)<0-2 and expected survival time 3 months or more; 6. At least one new antigen can induce T cell secrete interferon - gamma (IFN - gamma) twice as normal controls during the new antigens screening; 7. Without anticancer treatment more than one month; 8. Hematology Index including: Neutrophile granulocyte greater than 1.5×10^9/L; Hemoglobin greater than 10g/dL; Platelet greater than 100×10^9/L; 9. Biochemical index including: Serum bilirubin not greater than 1.5x upper limit of reference range (ULN); glutamic-pyruvic transaminase(ALT) or glutamic-oxalacetic transaminase(AST) not greater than 2.5x ULN; Creatinine clearance no less than 60ml/min; 10. Peripheral venous channel open and no contraindications to separating lymphocytes; 11. Negative pregnancy test for women of childbearing potential, and patients must be willing to practice birth control during the regimen; 12. Provision of informed consent; 13. Be able to follow the research program and follow up process.
Exclusion criteria
Exclusion criteria: 1. Those who now are undergoing other antitumor drug therapy (including chemotherapy, systemic steroids therapy, surgery, target therapy or immune therapy); 2. Prior treatment with PD-1 monoclonal antibody(mAb) or PD-L1 mAb; 3. Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the cervix; 4. History with pulmonary tuberculosis, and positive tests for Acquired Immune Deficiency Syndrome(HIV),hepatitis C virus(HCV),hepatitis B virus(HBV); 5. Patients with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism; Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including active severe infection, uncontrolled diabetes, angiocardiopathy (heart failure > class II New York Heart Association(NYHA), heart block >II grade, myocardial infarction, unstable arrhythmia or unstable angina within past 6 months, cerebral infarction within past 3 months) or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm); 7. Evidence with central nervous system(CNS) disease; 8. Pregnant or nursing; 9. Psychiatric medicines abuse without withdrawal, or history of psychiatric illness; 10. Hypersensitivity to investigational drugs or its components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| heart rate;breath;blood pressure;temperature;routine blood test;routine urine test;routine stool test;blood coagulation function test;blood biochemical test;electrocardiogram examination;thyroid function test;body weight;ECOG Grade;Activities of Daily Living Scale;CT scan;MRI;ORR;DCR;TTP;Evaluation of tumor size with criteria of Recist; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCR;peripheral blood cytokine test;tumor mutation burden; | — |
Countries
China
Contacts
Public ContactJiao Shunchang
The General Hospital of People's Liberation Army(301 hospital)
Outcome results
None listed