Immunotherapy for Third Line Metastatic Colorectal Cancer

Sponsor: Mirror Biologics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04444622

Provider View

This clinical trial is testing a new type of immunotherapy called AlloStim for patients with metastatic colorectal cancer who have already tried two different chemotherapy treatments. The study aims to see if this new treatment can help the immune system fight cancer more effectively.

Patient Parameters

Program Overview

This study is exploring a new immunotherapy treatment called AlloStim for patients with metastatic colorectal cancer who have not responded to two previous chemotherapy treatments. AlloStim is a living immune cell product made from the blood of healthy donors. It is designed to help the patient's immune system recognize and attack cancer cells. The treatment is not genetically modified and is intended to be safe and non-toxic, being naturally eliminated by the body within 24 hours. The goal is to train the immune system to fight cancer more effectively and prevent its growth and spread.

Description

This clinical trial is testing a new immunotherapy called AlloStim for patients with metastatic colorectal cancer who have already tried two different chemotherapy treatments. AlloStim is made from immune cells taken from healthy donors and is designed to help the patient's immune system fight cancer. Unlike other immune therapies that directly attack cancer cells, AlloStim works by training the patient's immune system to recognize and destroy cancer cells on its own. The treatment is safe and is naturally removed from the body within a day. The study aims to see if AlloStim can improve the body's ability to fight cancer and prevent it from spreading.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18-80 years old.
  • Diagnosed with colorectal cancer that has spread to other parts of the body.
  • Have tried two different chemotherapy treatments, including one with oxaliplatin and one with irinotecan.
  • If the cancer is KRAS wild type, must have tried at least one anti-EGFR therapy.
  • Cancer must have progressed during or shortly after the last treatment.
  • Be in good overall health with a performance status score of 0 or 1.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women must not be pregnant or breastfeeding and must agree to use contraception.
  • Must be able to provide informed consent in their native language.

Exclusion Criteria

  • Have high frequency microsatellite instability (MSI-H).
  • Have bowel obstruction or high risk for obstruction.
  • Have moderate or severe fluid buildup in the abdomen requiring treatment.
  • Have cancer that has spread to the brain or spinal fluid.
  • Have cancer spread in the abdominal lining.
  • Have symptomatic asthma or COPD.
  • Have lung issues requiring treatment or low oxygen levels.
  • Have received Bevacizumab (Avastin®) within 6 weeks of a scheduled biopsy.
  • Have certain mood disorders or history of suicidal thoughts.
  • Have had a bone marrow or organ transplant.
  • Use high doses of corticosteroids for more than 2 weeks recently.
  • Have an active autoimmune disease, except well-controlled Type I diabetes.
  • Have had prior experimental therapy.
  • Have a history of blood transfusion reactions.
  • Have an active infection that hasn't been resolved for at least 7 days.
  • Have symptomatic heart disease.
  • Have HIV or AIDS.
  • Take medications that affect blood clotting unless they can be stopped before procedures.
  • Have severe allergies to monoclonal antibody drugs.
  • Have psychiatric or addictive disorders that would interfere with participation.
  • Cannot provide consent for themselves.

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