Study on LN-145, Using a Patient's Own Immune Cells to Treat Cervical Cancer

Sponsor: Iovance Biotherapeutics, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03108495

Provider View

This clinical trial is testing a new treatment that uses a patient's own immune cells, called tumor infiltrating lymphocytes (TIL), to fight cervical cancer that has come back, spread, or is not responding to other treatments.

Patient Parameters

Program Overview

The study is exploring a treatment where a patient's own immune cells, known as tumor infiltrating lymphocytes (TIL), are collected, grown in a lab, and then infused back into the patient to help fight cervical cancer. This is followed by a medication called IL-2 to support the immune cells. The treatment is for patients with cervical cancer that has returned, spread, or is persistent despite other treatments.

Description

LN-145 is a type of treatment that uses a patient's own immune cells to target cervical cancer. The process involves collecting these cells from the patient, growing them in a lab, and then infusing them back into the patient after a special preparation that reduces certain blood cells. This is followed by a medication called IL-2 to help the immune cells work better. The study is for patients with cervical cancer that has come back, spread, or is not responding to other treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older. Patients over 70 may join after consulting with the study team.
  • Have cervical cancer that has returned, spread, or is persistent and cannot be cured with surgery or radiation.
  • Have at least one tumor that can be removed for cell collection, with minimal risk and short hospital stay.
  • Have at least one measurable tumor for tracking.
  • Have had one to three previous chemotherapy treatments for cervical cancer.
  • For Cohort 2: Must have received a checkpoint inhibitor treatment.
  • For Cohort 3 (U.S. only): Must not have had treatments other than chemoradiation or surgery for local disease.
  • Must stop any cancer treatments at least 28 days before cell collection.
  • Have a good performance status (ECOG 0 or 1).
  • Have adequate organ function.
  • No active infections requiring treatment and must be HIV negative. Hepatitis infections must be controlled.
  • Women of childbearing potential must use effective birth control during and for 12 months after treatment.
  • Must show disease progression after the most recent therapy before joining the study.

Exclusion Criteria

  • Have had an organ transplant or previous cell therapy, except for LN-145 re-treatment.
  • Require ongoing steroid treatment above a certain dose.
  • Have unresolved side effects from previous treatments, except for certain conditions like hair loss.
  • Have allergies to any study drugs or components.
  • Have active infections or major medical conditions affecting the heart, lungs, or immune system.
  • Have untreated or symptomatic brain metastases.
  • Have primary immune deficiencies or require dialysis.
  • Have certain heart or lung function issues.
  • Have had another cancer within the last 3 years, except for certain treated cancers.
  • Be pregnant, breastfeeding, or unable to consent.
  • Have received a live vaccine recently.
  • Have cancer needing immediate treatment or would be disadvantaged by joining the study.
  • For Cohorts 1 and 3: Have had previous immunotherapy.
  • Have had significant bleeding recently.
  • For Cohort 3: Have active or past autoimmune or inflammatory disorders.

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