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RECRUITING
NCT06538012
PHASE1/PHASE2

TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer

Sponsor: Essen Biotech

View on ClinicalTrials.gov

Summary

This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory lung cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to lung cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.

Official title: Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Pembrolizumab Immunotherapy in Patients With Advanced or Metastatic Refractory Lung Cancer

Key Details

Gender

All

Age Range

16 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2024-08-20

Completion Date

2026-12-28

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

Tumor Infiltrating Lymphocytes (TIL)

Tumor Infiltrating Lymphocytes (TIL) IV

DRUG

Cyclophosphamide

Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.

DRUG

Fludarabine

Fludarabine will be administered as an intravenous (IV) infusion for five days.

DRUG

Interleukin-2

After TIL infusion, IL-2 will be started as a bolus administration every eight hours, for a maximum of eight doses.

DRUG

Pembrolizumab

Intravenous (IV) infusion

Locations (1)

District One Hospital

Beijing, Beijing Municipality, China