Study on LN-145 or LN-145-S1 for Treating Patients with Certain Types of Cancer That Have Returned or Not Responded to Treatment

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03449108

Provider View

This clinical trial is testing a new treatment using a patient's own immune cells to target and kill cancer cells in patients with ovarian cancer, triple negative breast cancer, anaplastic thyroid cancer, osteosarcoma, or other bone and soft tissue sarcomas that have returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring how well a new treatment using a patient's own immune cells, called LN-145 or LN-145-S1, works in treating certain types of cancer that have come back or not responded to treatment. The treatment involves collecting and growing special white blood cells from the patient's tumor, which are then used to target and kill cancer cells. The study aims to see how effective this treatment is in shrinking tumors and improving survival rates, as well as to understand its safety and impact on quality of life.

Description

The main goal of this study is to see how well the treatment works in shrinking tumors in patients with specific types of cancer. Researchers will also look at how long the treatment effects last, how it affects survival, and its safety. The study will also explore how the treatment changes the immune system and tumor environment.

Patients will be divided into two groups based on their type of cancer. One group will receive a combination of chemotherapy and the LN-145 treatment, while the other group will receive additional immune therapy drugs before and after the LN-145 treatment. Patients will be monitored closely for side effects and the effectiveness of the treatment over several months and years.

The study involves several steps, including collecting immune cells from the patient's tumor, growing them in the lab, and then infusing them back into the patient. Patients will also receive chemotherapy and other supportive treatments to help the immune cells work effectively. Follow-up visits will occur at regular intervals to monitor the patient's health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Age between 18 and 70 years old (16-70 for osteosarcoma patients).
  • Willing and able to provide informed consent (or have a guardian provide consent for minors).
  • Good overall health with a performance status of 0 or 1.
  • Have a tumor that can be biopsied for immune cell collection.
  • Have stopped previous cancer treatments at least 28 days before starting the study.
  • Meet specific blood count and organ function criteria.
  • Negative pregnancy test for women of childbearing potential.
  • No HIV infection.
  • Meet specific heart and lung function criteria.
  • Willing to use effective birth control during and after the study.
  • Specific criteria for each cancer type, such as previous treatment history and tumor characteristics.

Exclusion Criteria

  • Have uncontrolled illnesses or infections.
  • Have active viral hepatitis.
  • Have a heart function below a certain level.
  • Have had previous cell therapies.
  • Have unresolved side effects from previous treatments.
  • Have primary immune deficiencies or have had organ transplants.
  • Are pregnant or nursing.
  • Have significant psychiatric conditions.
  • Have certain autoimmune diseases or lung diseases.
  • Have had another cancer in the last 5 years, with some exceptions.
  • Have active brain metastases.
  • Have received a live vaccine recently.
  • Have allergies to study drugs or components.
  • Have any condition that increases the risk of participation.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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