Study on CAR.70-Engineered IL15-Modified Cord Blood NK Cells with Chemotherapy for Advanced Kidney, Lung, and Bone Cancers

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05703854

Provider View

This clinical trial is testing a new treatment using modified natural killer (NK) cells from donated cord blood, combined with chemotherapy, to treat advanced kidney cancer, mesothelioma, and osteosarcoma. The study aims to find the best dose and evaluate the treatment's effects.

Patient Parameters

Program Overview

The purpose of this study is to find the best dose of donated NK cells that have been genetically modified to target cancer cells, and to see how well this treatment works when combined with chemotherapy in patients with advanced kidney cancer, mesothelioma, or osteosarcoma. Researchers will also study the effects of this therapy on the body and its ability to fight tumors.

Description

The main goals of this study are to determine the safety and best dose of CAR.70/IL15-modified NK cells from cord blood in patients with advanced kidney cancer, mesothelioma, and osteosarcoma. The study will also look at how well these cells can fight tumors. While the benefits of this treatment are not yet known, it is hoped that it will help reduce tumors and improve symptoms. Patients will be closely monitored for safety and any changes in their cancer.

Secondary goals include understanding how long the modified NK cells stay in the body, studying the immune system's response, and gathering information on patients' quality of life and experiences during the trial.

Eligibility Criteria

Inclusion Criteria

  • Have advanced kidney cancer, mesothelioma, or osteosarcoma with a specific marker (CD70) present in the tumor.
  • Meet specific criteria for each type of cancer:
    • Kidney cancer: Must have stage 4 clear cell type, have tried at least one previous treatment, and have a measurable tumor.
    • Mesothelioma: Must have confirmed diagnosis, tried all standard treatments, and have measurable disease.
    • Osteosarcoma: Must have confirmed diagnosis, tried standard treatments, and have progressive disease.
  • Be at least 2 weeks from last chemotherapy or targeted therapy.
  • Be at least 3 months from any previous cell therapy.
  • Have good overall health with a performance status of 0 or 1.
  • Have adequate organ function, including kidney, liver, heart, and lung health.
  • Be aged 16-80 years and weigh at least 40 kg.
  • Agree to use effective birth control during and after the study.
  • Provide informed consent and, if applicable, pediatric assent.

Exclusion Criteria

  • Have ongoing significant side effects from previous cancer treatments.
  • Have active infections requiring IV treatment.
  • Have active hepatitis B or C, or HIV with detectable viral load.
  • Have active neurological disorders or autoimmune diseases.
  • Have other serious medical conditions, such as severe heart disease or recent heart attack.
  • Have had major surgery within 4 weeks before starting the study.
  • Be using other investigational or anticancer agents.
  • Be pregnant or breastfeeding.

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