Advanced pancreatic cancer, lung cancer and colorectal cancer
Conditions
Interventions
experimental group:TCR-T treatment
Sponsors
Intervention and Cell Therapy Center, Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, no gender limit; 2. For patients with measurable and pathologically proven advanced pancreatic cancer, lung cancer, or colorectal cancer who failed first-line or second-line therapy, or who were unwilling/intolerant to targeted drug therapy, the expected overall survival time was more than half a year, including metastatic (having received regular chemotherapy), recurrent (having previously received surgery and adjuvant chemotherapy), locally advanced pancreatic cancer, lung cancer, or colorectal cancer with disease progression after neoadjuvant therapy; 3. Patients' tumors must express KRAS G12V, G12D, or G12C mutations as determined by DNA or RNA sequencing methods; No serious underlying diseases; 4. Patients must be HLA-A*11:01; Can be enrolled to receive KRAS G12V, G12D, G12C corresponding mutant antigen specific TCR-T cell therapy; 5. Patients should have good clinical performance status (ECOG 0 or 1); 6. No significant heart, lung, or renal insufficiency; 7. No HIV, HBV, HCV or syphilis infection; 8. Baseline hematological criteria: absolute neutrophil count of at least 1000/mm^3; A white blood cell count of at least 3000/mm^3; A platelet count of at least 75,000 per mm^3; Hemoglobin >8.0g/dL; 9. Baseline chemical criteria: serum ALT/AST is 5.0 x ULN or less; Total bilirubin is less than or equal to 1.5 mg per deciliter, unless the patient has Gilbert's syndrome, in which case it must be less than or equal to 3.0 mg per deciliter; eGFR>60 mL/m or 6-24 hours CrCl>60 mL/m; 10. All patients should sign informed consent at enrollment.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding patients; 2. Patients with any form of primary immunodeficiency (e.g. severe combined immunodeficiency disease or HIV); 3. Patients with active systemic infections, coagulation disorders or any other major medical diseases; 4. Patients with opportunistic infections; 5. Being treated with systemic glucocorticoids; 6. Patients allergic to cyclophosphamide, fludarabine and IL-2; 7. Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction in the past 6 months, and prolonged QT interval (> 450 ms); 8. The patient cannot be followed up or is participating in other clinical trials; 9. The investigator judged that the patient was not suitable to participate in the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response (CR);partial response (PR);stable disease (SD);progressive disease (PD);objective response rate (ORR);duration of response (DOR);tumor marker (TM);dose limited toxicity (DLT);markers of infection; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCR-T gene copy number;number of TCR-T cells;cell factor;immune markers; | — |
Countries
China
Contacts
Public ContactChen Junhui
Peking University Shenzhen Hospital
Outcome results
None listed