Advanced Pancreatic Cancer and Other Solid Tumors
Conditions
Interventions
1:TCR-T cell therapy
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Age greater than 18 years old; 2. Pathological diagnosis of recurrent/metastatic pancreatic cancer and other solid tumors (except intracranial metastasis). Patients who have had prior therapy with at least one standard treatment regimen remain in stable or progressive disease states and refuse subsequent chemotherapy; 3. Mutations in KRAS G12V or G12D and expression of matched HLA subtypes were confirmed in previous tumor or biopsy tissues; 4. Expected survival duration of more than 3 months; 5. ECOG score=2; 6. All subjects voluntarily participated in this study and signed an informed consent. And the subjects have good compliance and can cooperate with investigators follow-up study; 7. Patients at least have had at least one measurable lesion as defined by RECIST v1.1 criteria; 8. Female participants could not be pregnant or lactating and their serum or urine HCG tests must be negative within 72 hours prior to study enrollmentAll subjects must be using a medically accepted means of contraception ( (e.g., oral contraceptives, intrauterine device) during the course of this study and for at least 3 months after completion of study therapy. 9. Organ function and bone marrow reserve are in good condition, and the following requirements must be met: 1) Absolute neutrophil count=1.5×10^9/L 2) Platelet count=75×10^9/L 3) Hemoglobin=9g/dl 4) Bilirubin <1.5 times upper limit of normal(Bile duct obstruction due to tumor compression were excluded) 5) Serum creatinine = 1.5 times the upper limit of normal range or creatinine clearance = 60 mL/min. 6) Serum ALT or AST is <?2.5 times the upper limit of the normal value( ULN) (if patients with liver metastasis, =5 times the ULN). 7) Coagulation function normalisedINR=1.5PTT<1.2 times the upper limit of normal(Tumor - related anticoagulant therapy was excluded).
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Use of immunosuppressants or glucocorticoids within 1 week before enrollment; 2. Patients with moderate or severe hydrothorax need drain placement to relieve symptoms. 3. Human immunodeficiency virus (HIV) positive 4. Active Hepatitis B or Hepatitis C infection 5. Pregnant women and lactating females 6. Previous or concurrent history of other malignant tumors. Exceptions include curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy; 7. Patients with central nervous metastases 8. Serious, uncontrolled comorbidities that may affect protocol compliance or interfere with interpretation of resultsor any serious medical condition that may affect the safety of the subjects (eg, unstable cardiovascular disease, high-risk hypertension, active and uncontrolled infections ); 9. History of clinically significant respiratory diseases or other respiratory diseases that seriously affect Pulmonary function; 10. Any active autoimmune diseaseany condition requiring steroid hormones or immunosuppressive therapy( including but not limited to systemic lupus erythematosus, sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc., require > 10 mg/D of prednisone or equivalent hormone) 11. A history of organ transplantation 12. Subjects who received chemotherapy other than conditioning chemotherapy in the 2 weeks prior to cell infusion. 13. Patients have received gene therapy previously 14. Live vaccines were administered within 4 weeks prior to the study 15. A history of myocardial infarction and severe arrhythmia within six monthsIneligible were also patients with uncontrolled hypertension, coronary heart disease, stroke, liver cirrhosis, nephritis and other serious complications; 16. Those who have a history of psychotropic drug abuse and cannot quit or have a history of psychiatric impairment 17. Participants with an allergic constitution, known sensitivity to human serum albumin, cyclophosphamide, fludarabine and interleukin 2; 18. Those with bleeding or thromboembolic tendencybleeding symptoms of clinical significance or a clear tendency to bleeding within 2 weeks prior to entering the studysuch as gastrointestinal bleeding, hemorrhagic gastric ulcer, abnormal coagulation function, etc. And those with hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.)More serious arterial/venous thromboembolic events, such as cerebrovascular diseases (including cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc. (except stabilized local venous thrombosis) occurred in the previous 6 months; 19. Other severe, acute or chronic medical or mental illnesses that in the investigators judgement will might be increase the risk associated with the patients participation in the study or interfere with interpretation of research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| efficiency;PK/PD; | — |
Countries
China
Contacts
Public ContactZhang Meng
Outcome results
None listed