Study on Gemcitabine and Special Immune Cells with or without Naxitamab for Treating Metastatic GD2 Expressing, HER2 Negative Breast Cancer

Sponsor: Margaret Gatti-Mays

Sponsor score: 0

ClinicalTrials ID:NCT06026657

Provider View

This clinical trial is testing a new treatment combination for patients with a specific type of breast cancer that has spread. The study aims to find out if using gemcitabine, a chemotherapy drug, along with special immune cells and possibly naxitamab, can effectively target and kill cancer cells.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with metastatic breast cancer that expresses GD2 and is HER2 negative. The treatment involves using gemcitabine, a chemotherapy drug, along with specially modified immune cells called TGFBi NK cells, which are designed to better recognize and destroy cancer cells. Some patients will also receive naxitamab, an antibody that helps the immune system target cancer cells. The study aims to determine the safety and effectiveness of these treatments in shrinking tumors and improving patient outcomes.

Description

The main goals of this study are to evaluate the safety and effectiveness of combining gemcitabine with TGFBi NK cells, with or without naxitamab, in treating metastatic breast cancer. Researchers want to see if this combination can improve the response rate and extend the time patients live without the cancer getting worse, compared to using gemcitabine alone.

Participants will be divided into four groups:

  • Group 1: Receives gemcitabine and TGFBi NK cells.
  • Group 2: Receives gemcitabine and TGFBi NK cells on two different days.
  • Group 3: Receives gemcitabine, naxitamab, and TGFBi NK cells.
  • Group 4: Receives gemcitabine, naxitamab, and TGFBi NK cells on two different days.

Each treatment cycle lasts 28 days, and patients can continue for up to a year if the cancer does not progress and side effects are manageable. Throughout the study, patients will undergo scans and blood tests to monitor their response to the treatment.

After completing the treatment, patients will have follow-up visits within 30 days and every three months for a year to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of HER2 negative metastatic breast cancer that expresses GD2.
  • Have measurable cancer that can be tracked using standard criteria.
  • Have received at least one prior treatment for metastatic cancer and either did not respond or could not tolerate it.
  • Be 18 years or older.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1,500/mcL.
    • Platelet count of at least 100,000/mcL.
    • Hemoglobin level of at least 9 mg/dL.
    • Normal kidney and liver function as indicated by specific blood tests.
  • Women of childbearing potential must agree to use effective contraception during the study and for seven months after the last dose.
  • Men must agree to use effective contraception during the study and for six months after the last dose.
  • Patients with well-controlled HIV or hepatitis infections may be eligible if certain conditions are met.
  • Be able to understand and willing to sign informed consent.

Exclusion Criteria

  • Have received chemotherapy, investigational drugs, or radiation within three weeks before starting the study.
  • Have active brain or spinal cord cancer spread, unless treated and stable for six months.
  • Have had another invasive cancer within the past three years, except for certain skin or cervical cancers.
  • Have severe allergic reactions to similar drugs used in the study.
  • Have uncontrolled illnesses, such as infections or heart conditions, that could interfere with the study.
  • Have started bone-strengthening treatments like denosumab or bisphosphonates within 28 days before or after starting the study.
  • Have autoimmune diseases or conditions that affect the immune system, unless well-controlled.
  • Be pregnant or breastfeeding, or not using effective contraception if of childbearing potential.
  • Have significant heart disease or recent heart attack.
  • Have received live vaccines within 30 days before starting the study.
  • Have any other condition that, in the opinion of the study doctor, makes participation unsafe or affects the study's integrity.

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