RecruitingPhase 1Phase 2NCT06532812

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


Sponsor

Essen Biotech

Enrollment

85 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests TIL (tumor-infiltrating lymphocyte) therapy — where immune cells from the patient's own tumor are grown in a lab and reinfused — combined with immunotherapy drugs, for women with advanced or metastatic breast cancer that has not responded to standard treatments. TIL therapy is a personalized approach that uses the patient's own immune system to fight cancer more aggressively. **You may be eligible if...** - You are 16 to 90 years old with confirmed advanced, relapsed, or metastatic breast cancer - Your cancer has failed standard treatment or no standard treatment is available - You have a tumor accessible for biopsy to generate TIL therapy - You have at least one measurable tumor on a scan - You are in reasonably good health (Karnofsky score ≥60 or ECOG 0-2) - Your blood counts and organ function meet minimum thresholds **You may NOT be eligible if...** - You require high-dose daily steroids (more than 15mg prednisone) - You have active autoimmune disease requiring treatment - You are pregnant or not using adequate contraception - You have received other cancer treatments within 28 days of tumor removal for TIL - You have serious heart, kidney, or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTumor Infiltrating Lymphocytes (TIL)

Tumor Infiltrating Lymphocytes (TIL) IV

DRUGCyclophosphamid

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

DRUGFludarabine

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

DRUGInterleukin-2

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

DRUGPembrolizumab

Intravenous (IV) infusion


Locations(1)

District One Hospital

Beijing, Beijing Municipality, China

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NCT06532812


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