Advanced malignant tumors
Conditions
Interventions
A: Knock out PD1 autologous activated immune T cells
Sponsors
105th Hospital of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of advanced, recurrent or metastatic malignant tumors including, but not limited to, pancreatic cancer, colorectal cancer, liver cancer, gastric cancer, non-small cell lung cancer, breast cancer, etc.; 2. At least 2 weeks since prior Radiotherapy and must have recovered from them completely; 3. ECOG performance status 0-2; 4. Life expectancy = 12 weeks; 5. Subjects must be 18-75 years of age, both male and female; 6. Laboratory values must fulfill all of the following criteria: absolute neutrophil count(ANC) =1.5×10^9/L, platelets=80×10^9/L, hemoglobin=100g/L, AST and ALT=2.5×upper limit of normal(ULN)(AST and ALT=5×ULN in the case(s) of primary liver cancer, liver metastases or pancreatic cancer), calculated creatinine clearance(CCr) =60ml/min or creatinine(Cr)=1.5×ULN; 7. Women of childbearing potential must use an approved contraception and must have a negative serum or urine pregnancy test at screening, and must not be breast-feeding; 8. Male must be surgically sterile or compliant with an adequate contraception during, and for 3 months after the treatment; 9. Patients compliance with follow-up is required; 10. Ability to understand and the willingness to sign a written informed consent form, the signed informed consent must be obtained prior to performing any study specific procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with known allergy to interleukins; 2. Drug addiction or alcohol dependence; 3. Received any other investigational agents or non-approved drugs within 4 weeks preceding the first dose of investigational product; 4. Having following diseases or conditions: Newly diagnosed CNS metastases without surgery; Any serious, uncontrolled or unstable systematic diseases (including, but not limit to, active infection, grade III hypertension, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases); History of neurologic or psychiatric disorders, etc.; 5. Any concurrent anti-tumor therapy during the study; 6. Pregnant or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T cell population;CD4/CD8 ratio;Contents of plasma immunoglobulin; | — |
Contacts
Public ContactBo Liu
Department of Infection, 105th Hospital of PLA
Outcome results
None listed