drugset / Trial / NCT03801083
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 2 study to evaluate the efficacy, using objective response rate, of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous Tumor Infiltrating Lymphocytes (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic biliary tract cancer. These are low-incidence cancers carry a poor prognosis. Participants will include patients with biliary tract cancers (BTC), including cholangiocarcinoma (both intrahepatic and extrahepatic) and gallbladder cancer, who are and are physically able to tolerate non-myeloablative chemotherapy and high-dose aldesleukin.
Timeline
- Start
- 2019-02-19
- Primary completion
- 2030-01-31
- Completion
- 2031-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | 2e+11 cells | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | 600000 iu/kg | Intravenous |