NCT06532812

TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Essen Biotech · Academic / Other
• Sex: All
• Age: 16 Years – 90 Years
• Healthy volunteers: Not accepted

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 breast 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 that targets 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 provide a novel, personalized treatment option for patients with limited therapeutic alternatives.

Detailed description

Tumor-infiltrating lymphocytes (TILs) therapy is an advanced form of adoptive cell therapy that harnesses the patient's immune cells to fight cancer. This therapy involves extracting lymphocytes from the tumor, expanding them ex vivo, and reinfusing them into the patient to target and kill cancer cells. This study focuses on combining TIL therapy with Pembrolizumab (Keytruda) and Aldesleukin (IL-2) to enhance the anti-tumor immune response in patients with advanced or metastatic refractory breast cancer, conditions that typically have a poor prognosis and limited treatment options. This trial involves a multi-step treatment process. First, tumor samples are collected from patients for TIL extraction. Following this, a lymphodepletion regimen using cyclophosphamide and fludarabine is administered to prepare the body for the infusion of expanded autologous TILs. After the TIL infusion, Aldesleukin (IL-2) is given to stimulate the TILs' activity. Pembrolizumab (Keytruda), an immunotherapy that targets the PD-1 receptor on T cells, is also administered to further enhance the immune response against the tumor. The primary goal of this trial is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and changes in the quality of life (QoL) of patients. Patients will be closely monitored for side effects and reactions during their hospital stay and throughout the follow-up period. Safety will be assessed based on the incidence and severity of adverse events, while efficacy will be evaluated using RECIST v1.1 criteria. By leveraging the patient's own immune cells and combining them with advanced immunotherapies, this trial aims to provide a novel, personalized treatment option for patients with advanced or metastatic refractory breast cancer.

Conditions

• Breast Cancer
• Breast Carcinoma
• Breast Cancer Metastatic
• Breast Cancer Triple Negative

Interventions

Type	Name	Description
BIOLOGICAL	Tumor Infiltrating Lymphocytes (TIL)	Tumor Infiltrating Lymphocytes (TIL) IV
DRUG	Cyclophosphamid	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

Timeline

• Start date: 2024-08-22
• Primary completion: 2025-12-10
• Completion: 2026-12-28
• First posted: 2024-08-01
• Last updated: 2024-11-12

Locations

1 site across 1 country: China