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

NCT06532812 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Essen Biotech

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2025-12-10
Completion
2026-12-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06532812 on ClinicalTrials.gov