Study on KSQ-001EX, a New Treatment Using Modified Immune Cells for Advanced Solid Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06237881

Provider View

This clinical trial is testing a new treatment called KSQ-001EX, which uses a patient's own immune cells that are modified to fight cancer. The study aims to determine if this treatment is safe and effective for people with advanced solid tumors, such as melanoma, head and neck cancer, and non-small cell lung cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if KSQ-001EX, a treatment using modified immune cells, is safe for patients with advanced solid tumors. The study will also evaluate how well the treatment works in shrinking tumors and its overall safety. Participants will receive KSQ-001EX and be monitored for any side effects and changes in their cancer.

Description

This study is divided into two phases. In Phase I, the main goal is to assess the safety and tolerability of KSQ-001EX in adults with advanced solid tumors, including melanoma, head and neck cancer, and non-small cell lung cancer. Researchers will look for any side effects and determine the best dose for future studies. They will also evaluate the initial effectiveness of the treatment and the feasibility of producing it.

In Phase II, the focus is on assessing how well KSQ-001EX works in reducing tumors in patients with advanced solid tumors. Researchers will continue to monitor safety and look at overall survival rates. They will also explore how the treatment affects the immune system and its persistence in the body.

Throughout the study, participants will undergo various tests and evaluations to track their health and the treatment's impact. The study aims to provide valuable insights into the potential of KSQ-001EX as a new cancer treatment option.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced melanoma, non-small cell lung cancer (NSCLC), or head and neck cancer (HNSCC) that has not responded to previous treatments.
  • Have a tumor that can be surgically removed for KSQ-001EX manufacturing.
  • Have at least one measurable tumor after surgery.
  • Aged between 18 and 70 years old.
  • Have a life expectancy of at least 12 weeks.
  • Have recovered from previous cancer treatments to a certain level.
  • Have a good performance status, meaning they are fully active or have some restrictions but can still perform light work.
  • Have adequate bone marrow, kidney, and liver function based on specific blood tests.
  • Have not received certain cancer treatments within a specified time before starting the study.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study. Men must agree to use condoms during and after the study.
  • Able to understand and agree to the study requirements and sign an informed consent form.

Exclusion Criteria

  • Have had a previous organ transplant or certain cell therapies.
  • Have allergies to any components of KSQ-001EX or related treatments.
  • Have active or past autoimmune or inflammatory disorders, with some exceptions.
  • Have allergies to certain antibiotics.
  • Have an active, uncontrolled infection requiring IV antibiotics.
  • Have certain types of melanoma or lung cancer.
  • Have untreated or symptomatic brain metastases.
  • Are pregnant or nursing.
  • Have certain viral infections like HIV, hepatitis B, or hepatitis C, unless controlled.
  • Have a primary immunodeficiency or significant liver disease.
  • Need to take high doses of steroids.
  • Have had a recent stroke, heart attack, or severe heart condition.
  • Have certain lung conditions or require oxygen during a walk test.
  • Have a history of other active cancers, with some exceptions.
  • Have a psychiatric illness that would interfere with the study.
  • Have any other severe medical condition that would increase the risk of participating in the study.

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