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RECRUITING
NCT03801083
PHASE2

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers

Sponsor: Udai Kammula

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Locally Advanced, Recurrent, or Metastatic Biliary Tract Cancers

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2019-02-19

Completion Date

2031-01-31

Last Updated

2025-07-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Tumor Infiltrating Lymphocytes (TIL)

TIL are to be infused intravenously through a central vein catheter over 20-30 minutes followed by Aldesleukin, administered at a dose of 600,000 IU/kg (based on total body weight) as an intravenous bolus over a 15-minute period approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to a maximum of 6 doses.

Locations (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States