RecruitingPhase 2NCT03801083

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers

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

Sponsor

Udai Kammula

Enrollment

59 participants

Start Date

Feb 19, 2019

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer Cholangiocarcinoma Biliary Tract Neoplasms

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a treatment called adoptive TIL therapy for biliary tract cancers — which include cancers of the bile ducts, gallbladder, and related structures. The treatment involves collecting immune cells (tumor-infiltrating lymphocytes, or TILs) from inside the patient's own tumor, growing them in a lab to increase their numbers, and then infusing them back into the patient to fight the cancer. **You may be eligible if...** - You have been diagnosed with locally advanced, recurrent, or metastatic biliary tract cancer (bile duct, gallbladder, or related cancer) that can be measured on imaging - Your cancer cannot be removed by conventional surgery, OR it has spread and has stopped responding to standard treatments **You may NOT be eligible if...** - Your cancer is still surgically removable by standard approaches - You have not yet tried approved standard treatments for metastatic disease - You have severe immune system problems or other conditions that prevent safe use of this therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTumor 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.