Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer
This clinical trial will evaluate the safety and activity of mutant KRAS G12V-specific TCR transduced T cell therapy for advanced pancreatic cancer patients who express the KRAS G12V mutation and HLA-A\*11:01 allele. The theoretical basis of this study is that mutant KRAS antigen-specific TCR transduced autologous Tcel
| Condition(s) | Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Ductal Adenocarcinoma, Advanced Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This clinical trial will evaluate the safety and activity of mutant KRAS G12V-specific TCR transduced T cell therapy for advanced pancreatic cancer patients who express the KRAS G12V mutation and HLA-A\*11:01 allele. The theoretical basis of this study is that mutant KRAS antigen-specific TCR transduced autologous Tcells will target and kill HLA-matched mutant KRAS cancer cells but not normal cells. |
| Who can participate | Inclusion Criteria: * Patients with measurable and pathologically confirmed advanced pancreatic cancer, including metastatic pancreatic cancer (who have received standard chemotherapy) and recurrent pancreatic cancer (who have received surgery and adjuvant chemotherapy previously). * Patient's tumor must express the KRAS G12V mutation, or a G12V mutation in HRAS or NRAS, as determined by DNA or RNA sequencing methods. * Patients must be HLA-A\*11:01. * Patients with brain metastasis may be eligible if they are asymptomatic and there are fewer than 3 brain lesions that are each less than 1 cm in diameter. * Patients between 18 to 75 years old are eligible. * Patients should have good clinical performance status (ECOG 0 or 1). * Patients must practice birth control once enrolled into the stu |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Changhai Hospital |
| Locations | Shanghai, China |
| Start date | 2021-10-21 |
| NCT ID | NCT04146298 |
| Official listing | https://clinicaltrials.gov/study/NCT04146298 |