Relapsed and refractory advanced pancreatic cancer
Conditions
Interventions
Experimental group:Intravenous infusion of TCR-T cells
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, gender is not limited; 2. Patients with advanced pancreatic cancer who have failed first- or second-line therapy, or who are unwilling/intolerant of targeted drug therapy, including metastatic (received regular chemotherapy), recurrent (received surgery and adjuvant chemotherapy), locally advanced pancreatic cancer and other solid tumors after neoadjuvant therapy; 3. No serious underlying diseases; 4. Patients diagnosed with pancreatic cancer after biopsy or previous surgery, and those with KRAS G12V mutation and expressed HLA-A11:01 subtype can be enrolled to receive KRAS G12V corresponding 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. Be receiving systemic glucocorticoid therapy; 3. Patients who are allergic to cyclophosphamide, fludarabine and interleukin 2 drugs; 4. Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction in the past 6 months, QT interval prolongation (>450 ms); 5. Malignant tumors in other parts within the past 5 years. The patient cannot be followed up or is participating in other clinical trials; 6. The investigator judges that the patient is not suitable to participate in this study due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;time to progress (TTP);progression-free survival (PFS);overall survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| dose limited toxicity (DLT);the survival time of TCR-T cells in vivo;the functional status of TCR-T cells in vivo; | — |
Countries
China
Contacts
Public ContactChen Junhui
Peking University Shenzhen Hospital
Outcome results
None listed