RecruitingPhase 1Phase 2NCT06532799

TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer

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


Sponsor

Essen Biotech

Enrollment

75 participants

Start Date

Sep 10, 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 stomach and esophageal cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has shown significant promise in treating unresectable or metastatic melanoma by leveraging the patient's own immune cells to target and destroy cancer cells. This study aims to apply a similar approach to stomach and esophageal cancers. 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 whether combining tumor-infiltrating lymphocyte (TIL) therapy — where immune cells are taken from a patient's own tumor, grown in a lab, and infused back in — with pembrolizumab (an immunotherapy drug) can help people with advanced stomach cancer or esophageal cancer that has stopped responding to standard treatments. These are difficult cancers to treat once they've progressed, and this combination aims to harness the immune system more powerfully. **You may be eligible if...** - You are 16 to 90 years old with confirmed advanced, relapsed, or metastatic stomach or esophageal cancer - Your cancer has failed standard treatment or no standard treatment is available - You have a tumor that can be safely biopsied or removed to make the 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 need high-dose steroids (more than 15mg prednisone daily) - You have had recent cancer treatment (within 28 days of tumor removal for TIL) - You are pregnant or not using effective contraception - You have active autoimmune disease requiring treatment - You have active brain metastases or uncontrolled CNS disease 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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NCT06532799


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