drugset / Trial / NCT03801083

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers

NCT03801083

Phase 2 Active not recruiting 4 enrolled Udai Kammula
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

EvaluationDrugModalityDoseRoute
Subject Tumor Infiltrating Lymphocytes Cell therapy 2e+11 cells Intravenous
Background aldesleukin Protein / enzyme biologic 600000 iu/kg Intravenous

Indications