Actively Recruiting

Phase 1
Phase 2
Age: 16Years - 90Years
All Genders
NCT06538012

TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer

Led by Essen Biotech · Updated on 2024-10-15

85

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 lung cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to lung 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 targeting 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 offer a novel, personalized treatment option for patients with limited therapeutic alternatives.

CONDITIONS

Official Title

TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer

Who Can Participate

Age: 16Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 16 and 90 years
  • Histologically confirmed primary, relapsed, or metastatic lung cancer
  • Expected life span longer than 3 months
  • Karnofsky score of 60% or higher or ECOG score 0-2
  • Have failed standard treatments or have no standard treatment options
  • Tumor regions suitable for biopsy or resection, or malignant fluid available for TIL isolation
  • At least one tumor lesion that can be evaluated
  • Blood tests within 7 days before enrollment meeting specific counts for white blood cells, neutrophils, lymphocytes, platelets, and hemoglobin
  • Coagulation tests (APTT and INR) within acceptable limits unless on recent anticoagulants
  • Kidney and liver function tests within defined limits
  • No contraindications to surgery or biopsy
  • Women able to have children must use highly effective contraception during and for one year after lymphodepletion
  • Stopped any tumor-targeting therapies including chemo, radiotherapy, and biologics at least 28 days before TIL collection
  • Able to understand and sign informed consent
  • Able to comply with follow-up visits and study requirements
Not Eligible

You will not qualify if you...

  • Need glucocorticoid treatment with prednisone over 15mg daily or have autoimmune diseases needing immunomodulatory therapy
  • Lung function with forced expiratory volume (FEV1) less than 2 liters or lung diffusion capacity (DLCO) below 40%
  • Severe heart problems including NYHA Grade III/IV heart failure, low blood pressure, unstable coronary artery disease, low ejection fraction, or severe arrhythmias
  • Active infections including HIV, hepatitis B or C, syphilis
  • Severe physical or mental illness
  • Active systemic infection needing treatment or positive blood cultures
  • Receiving other medications, biologics, chemo, or radiotherapy within the past month
  • Allergies to substances similar to cell therapy
  • Previous immunotherapy causing severe immune-related adverse events above level 3
  • Ongoing adverse effects from prior cancer treatments not resolved to mild or better
  • Pregnant or breastfeeding women
  • History of organ or stem cell transplantation or renal replacement therapy
  • Other severe systemic diseases or conditions unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

District One Hospital

Beijing, Beijing Municipality, China, 086-373

Actively Recruiting

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Research Team

R

Rhoda M Smith, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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