NCT03108495

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Recurrent, Metastatic or Persistent Cervical Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Iovance Biotherapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma

Detailed description

LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.

Conditions

• Cervical Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	LN-145	A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
BIOLOGICAL	LN-145 + pembrolizumab	A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. The first dose of anti-PD-1 immunotherapy will be administered following tumor resection.

Timeline

• Start date: 2017-06-22
• Primary completion: 2025-08-22
• Completion: 2025-08-22
• First posted: 2017-04-11
• Last updated: 2025-09-17

Locations

43 sites across 8 countries: United States, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study