Clinical Trial

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

Study acronym: BAH249

Recruiting Phase 1/2

Record status

This record was last updated November 12, 2024 (before its estimated December 10, 2025 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2024-07-29; most recent amendment 2024-11-10.

Status change: Not Yet Recruiting → Recruiting 2024-08-24

Trial Details

NCT Number	NCT06532812
Lead Sponsor	Essen Biotech
Conditions	Breast Cancer, Breast Carcinoma, Breast Cancer Metastatic, Breast Cancer Triple Negative
Enrollment	85 participants
Start Date	2024-08-22
Primary Completion	2025-12-10 (estimated)
Study Completion	2026-12-28 (estimated)
Updated on ClinicalTrials.gov	2024-11-12