Study on Using Genetically Modified Immune Cells to Treat Metastatic Gastrointestinal Cancers

Sponsor: Intima Bioscience, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04426669

Provider View

This clinical trial is testing a new treatment that uses a patient's own immune cells, which are genetically modified to better fight cancer, for treating advanced gastrointestinal cancers. The study aims to determine if this approach is safe and effective in reducing tumors.

Patient Parameters

Program Overview

This study is exploring a new cancer treatment that involves taking a patient's immune cells from their tumor, genetically modifying them using CRISPR technology to enhance their ability to fight cancer, and then returning them to the patient's body. The main goals are to assess the safety of this treatment and to see if it can help shrink tumors in adults with advanced gastrointestinal cancers that have not responded to standard treatments.

Description

Researchers are testing a new therapy that uses a patient's own immune cells, called Tumor Infiltrating Lymphocytes (TILs), which are taken from their tumor and genetically modified to better attack cancer cells. This modification involves using CRISPR technology to inhibit a specific gene, CISH, which normally limits the immune cells' ability to fight cancer. By turning off this gene, the modified cells are expected to be more effective in targeting and destroying cancer cells.

The study aims to evaluate the safety and effectiveness of this approach in patients with metastatic gastrointestinal cancers. Participants will undergo a series of procedures, including the collection of tumor tissue and immune cells, genetic modification of these cells in the lab, and infusion of the modified cells back into the patient. The study will monitor the patients' health and the treatment's impact on their cancer over time.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced gastrointestinal cancer that has progressed after at least one standard treatment.
  • Have at least one tumor that can be surgically removed for cell collection and another measurable tumor to track treatment response.
  • Up to three small, asymptomatic brain tumors are allowed if they are stable after treatment.
  • Aged between 18 and 70 years old.
  • In good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Negative tests for HIV, hepatitis B, and hepatitis C, or have these conditions under control.
  • Adequate blood cell counts and organ function as indicated by specific blood tests.
  • More than four weeks since the last cancer treatment, with recovery from any side effects.
  • Willing to undergo a blood cell collection procedure and stay near the treatment center for follow-up visits.
  • Provide written consent to participate in the study.

Exclusion Criteria

  • Pregnant or breastfeeding women due to potential risks to the baby.
  • Have a primary immune deficiency or active infections requiring treatment.
  • Currently taking systemic steroids or have a history of severe allergic reactions to study drugs.
  • Have significant heart or lung conditions that could affect treatment safety.
  • Participating in another clinical trial or taking investigational drugs.
  • Must meet specific health criteria before starting the treatment, including adequate blood counts and organ function, and negative tests for certain infections.
  • Agree to use effective contraception during the study and for a specified period after treatment if of childbearing potential.

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