pancreatic cancer
Conditions
Interventions
experimental group:KRASG12V mutant antigen-specific TCR-T cell therapy
Sponsors
Jinling Hospital Affiliated to Nanjing University (Eastern Theater General Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Men or non-pregnant women with pancreatic cancer between the ages of 18 and 70. 2. Patients with advanced pancreatic cancer, including metastatic pancreatic cancer (received regular chemotherapy), recurrent pancreatic cancer (received surgery and adjuvant chemotherapy in the early stage), and locally advanced pancreatic cancer with disease progression after neoadjuvant therapy. 3. No serious underlying diseases. 4. Patients diagnosed with pancreatic cancer after biopsy or previous surgery, detected KRAS G12V mutation and expressed matching HLA-A*11:01 subtype can be enrolled to receive KRASG12V mutation antigen-specific TCR-T cell therapy. 5. No significant heart, lung and renal insufficiency, no HIV, HBV, HCV or syphilis infection. 6. All patients should sign an informed consent form when selected.
Exclusion criteria
Exclusion criteria: 1. The general condition is poor (ECOG>=2), and it is estimated that short-term chemotherapy and immune cell therapy cannot be tolerated. 2. Are receiving systemic glucocorticoid therapy. 3. Patients who are allergic to cyclophosphamide, fludarabine and interleukin 2 drugs. 4. Unstable angina, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction in the past 6 months, QT interval prolongation (>450ms). 5. Malignant tumors in other parts within the past 5 years. 6. The patient cannot receive follow-up or is participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency and severity of treatment-related adverse events;objective response rate;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;the functional status of TCR-T cells in vivo; | — |
Countries
China
Contacts
Public ContactWang Xinbo
Jinling Hospital Affiliated to Nanjing University (Eastern Theater General Hospital)
Outcome results
None listed