Study on CHM-2101 CAR T Cell Therapy for Advanced Gastrointestinal Cancers

Sponsor: Chimeric Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06055439

Provider View

This clinical trial is testing a new treatment called CHM-2101, a type of CAR T cell therapy, for patients with advanced gastrointestinal cancers that have not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new treatment called CHM-2101, which is a CAR T cell therapy designed to target advanced gastrointestinal (GI) cancers that have not responded to at least one standard treatment. The study aims to see if this therapy can help control the cancer in patients whose disease has spread or is locally advanced.

Description

This study is divided into two parts: Phase 1 and Phase 2. In Phase 1, researchers will determine the safest dose of CHM-2101 and expand the study to more patients. In Phase 2, they will further evaluate the effectiveness of the treatment.

Participants will first provide consent and undergo screening to ensure they meet the study criteria. This includes a procedure called leukapheresis, where white blood cells are collected from the blood. These cells are then modified in the lab to create the CHM-2101 therapy, which is later infused back into the patient.

If needed, patients may receive additional chemotherapy to keep the cancer stable while waiting for the CHM-2101 therapy to be ready. This additional chemotherapy cannot be given within two weeks before the leukapheresis or the CHM-2101 infusion.

Participants will be monitored for 18 months or until their cancer progresses.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Have a confirmed diagnosis of certain types of gastrointestinal cancers, such as gastric adenocarcinoma, colon or rectal adenocarcinoma, or specific neuroendocrine tumors.
  • Must have tumor tissue available for testing.
  • Have received at least one prior treatment for advanced cancer and have no other available treatment options.
  • Be between 18 and 85 years old.
  • Have measurable disease for certain phases of the study.
  • Be in good overall health with a performance status of 0 or 1.
  • Have a life expectancy of at least 12 weeks.
  • No known issues with the leukapheresis procedure or certain medications.
  • Meet specific blood and organ function criteria.
  • Have a heart function of at least 50%.
  • Test negative for HIV, hepatitis B, and hepatitis C.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.

Exclusion Criteria

  • Have previously received CDH17-targeted therapies.
  • Have unresolved side effects from previous treatments, except for mild, stable conditions.
  • Have uncontrolled seizures or known brain metastases.
  • Have a history of severe allergic reactions to similar treatments.
  • Have uncontrolled inflammatory bowel diseases or other GI disorders.
  • Have significant liver involvement.
  • Have an active infection requiring antibiotics.
  • Have certain lung or heart conditions.
  • Are taking high doses of steroids.
  • Have had another cancer within the past 5 years, except for certain skin or cervical cancers.
  • Are breastfeeding or planning to become pregnant soon.
  • Have any other serious health issues that would prevent participation.

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