bladder cancer
Conditions
Interventions
Sponsors
The Second People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Measurable non-small cell lung cancer, digestive tract cancer, kidney cancer, glioma, cervical cancer, breast cancer or melanoma by histologic or cytologic confirmation with at least one lesion that is resectable for isolation of cultured cells and sequencing analysis with minimal morbidity preferentially using minimal invasive laparoscopic or thoracoscopic surgery for removal of superficial tumor deposit, plus one other lesion that can be measured; 2. At least one measurable disease: diameter by spiral computed tomography(CT)is greater than or equal to 10mm, or the short diameter of malignant lymph nodes is greater than or equal to 15mm; 3. All patients must be refractory to approved standard systemic therapy; 4. Clinical performance status of ECOG 0 or 1; 5. Expected survival time at least 6 months; 6. aged 18 to 65 years; 7. Willing to practice birth control during treatment and for four months after receiving the treatment; 8. Able to understand and sign the Informed Consent Document; 9. Willing to follow clinical protocols and follow up procedures. 10. ematology: Absolute neutrophil count greater than 1500/mm(3) without support of filgrastim or Granulocyte colony stimulating factor (G-CSF). Normal WBC (> 3500/mm(3)) without support of G-CSF. Hemoglobin greater than 10 g/dl. Platelet count greater than 100,000/mm(3). Blood product transfusion is not allowed; 11. Chemistry: Serum ALT/AST less than the upper limit of normal.Serum creatinine and urea nitrogen less than the upper limit of normal. Total bilirubin less than less than the upper limit of normal. Except in patients with livermetastasis, who must have a total bilirubin less than or equal to 2 times the upper limit of normal(ULN), Serum ALT/AST less than five times the ULN, or patients with liver metastasis, who must have a Serum creatinine and urea?nitrogen less than or equal to 1.5 times the ULN, or 24-hours Creatinine clearance no less than 50ml/min; 12. Willing to draw peripheral blood through the vein, and there is no contraindication for the collection of peripheral blood mononuclear cells; 13. The results of oncogenic or immunohistochemical tests do not include known mutations that can be treated with approved targeted drugs.Or, although it contains known types of mutations that can be treated with approved targeted drugs, it is ineffective or resistant after the treatment with the corresponding targeted drugs.
Exclusion criteria
Exclusion criteria: 1. History of bone marrow transplantation, stem cell transplantation or organ transplantation; 2. Analysis of gene sequencing data has not found enough neoantigens for subsequent treatment; 3. The genotype of Human leukocyte antigen (HLA) is homozygous or lacking alleles; 4. Undergoing other systemic cancer treatment, such as chemotherapy, radiotherapy or target therapy; 5. Prior treatment with any other investigational agents within 4 weeks; 6. Prior treatment with PD-1 monoclonal antibody(mAb) or PD-L1mAb or other immunotherapy within 3 months, such as DC/CIK; 7. Received other vaccination within 4 weeks before treatment;Subjects were also not allowed to receive other vaccines eight weeks after the last transfusion; 8. Concurrent opportunistic infections,such as fungal infection or/and bacterial infection (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities); 9. Active systemic infections (e.g.: HIV, HCV, HBV or syphilis); 10. Patients with symptomatic brain metastases(except glioma); 11. Patients with definite hemorrhage of digestive tract or hemorrhagic tendency; 12. Patients with symptomatic ascite, or Child-Pugh Class B or C; 13. Patients with abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks; 14. Concurrent systemic steroid therapy, or/and immunosuppressant therapy. (Note: Patients with recurrent glioblastoma who require steroids for clinical indications are eligible); 15. Any gene therapy products have been used before; 16. Any form of primary immunodeficiency or history of major organ autoimmune disease, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism; 17. History of coronary revascularization or ischemic symptoms, or other diseases of important organs that are not controlled; 18. Patients with a history of psychotropic substance abuse who cannot be cured or have mental disorders; 19. History of severe immediate hypersensitivity reaction to any of the agents used in this study; 20. Drug abuse, clinical or psychological or social factors that affect informed consent or research implementation. 21. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant; 22. T cell transduction efficiency less than 30%, or insufficient response to CD3/CD28 co-stimulation of amplification(less than 5 times).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;routine blood test;routine stool test;blood coagulation function;blood biochemical test;tumor markers test;CRP;peripheral blood cytokine test;TCR;lymphocyte subgroup test;blood immune globulin test;HIV RNA;body weight;the recording of liquid intake and output;Life quality measurement scale;ECOG score;electrocardiogram examination;CT scan;MRI;Evaluation of tumor size with criteria of Recist;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS; | — |
Contacts
Public ContactWeiren Huang
The Second People's Hospital of Shenzhen
Outcome results
None listed