Actively Recruiting
Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer
Led by Margaret Gatti-Mays · Updated on 2025-07-08
42
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib/II trial tests the safety, best dose and how well gemcitabine and ex vivo expanded allogenic universal donor TGFBi NK cells with or without naxitamab work for the treatment of patients with GD2 expressing, HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. TGFBi NK cells are manufactured cells that are a part of your natural immunity. NK cells can recognize missing or incorrect proteins on tumor cells and then eliminate these tumor cells and TGFBi NK cells are created to be able to better kill the tumor cells. Naxitamab is a monoclonal antibody that targets GD2, which is a protein or sugar present on tumor cells but not very commonly found on normal cells. This antibody helps draw the attention of the immune system to the tumor cells that have GD2 to help attack the tumor cells. Giving gemcitabine and TGFBi NK cells with or without naxitamab may kill more tumor cells in patients with metastatic GD2 expressing, HER2 negative breast cancer.
CONDITIONS
Official Title
Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed HER2 negative metastatic breast cancer historically expressing GD2 with available archival tissue
- Measurable disease according to RECIST 1.1 criteria
- Received at least one prior treatment for metastatic disease and experienced progression or intolerance
- Male or female aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count of at least 1,500/mcL
- Platelet count of at least 100,000/mcL
- Hemoglobin level of at least 9 mg/dL (transfusion allowed within 24 hours before dosing)
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 60 mL/min
- Adequate liver function with AST and ALT levels less than or equal to 3 times upper limit of normal and total bilirubin less than 1.5 times upper limit of normal, except for Gilbert's syndrome cases
- Use of adequate contraception for women of childbearing potential and men during and after study participation
- Well-controlled HIV infection under effective antiretroviral therapy with viral suppression and CD4 count over 200 cells/µL
- Undetectable hepatitis B viral load on suppressive therapy if applicable
- History of hepatitis C infection treated and cured or undetectable RNA 12 weeks after treatment
- Ability and willingness to sign informed consent
- Resolution of prior treatment adverse events to grade 1 or less
You will not qualify if you...
- Receipt of chemotherapy, investigational agents, or radiation within 3 weeks prior to enrollment
- Active brain or leptomeningeal metastases, except treated brain metastases stable for 6 months
- Need for immunosuppressive corticosteroid doses greater than 10 mg/day prednisone equivalent
- History of another invasive cancer within 3 years, except certain skin or in situ cancers
- Allergic reactions to similar compounds as study agents
- Uncontrolled illnesses such as active infections requiring antibiotics, recent fever, unstable angina, cardiac arrhythmia, or psychiatric/social issues affecting compliance
- Recent start of denosumab or bisphosphonate therapy within 28 days around cycle 1 day 1
- Evidence of immunocompromise including active autoimmune diseases or altered immune function affecting response
- Immunosuppressive therapy post-organ transplant
- Chronic systemic steroid use above physiologic doses or recent corticosteroid use related to brain metastasis
- Pregnancy, breastfeeding, or inadequate contraception use
- Significant heart conditions or recent cerebrovascular accident
- History of myocarditis
- Live vaccines within 30 days before enrollment
- Any condition deemed by the investigator to make the patient a poor candidate
- Inadequate lung function with symptoms or abnormal oxygen levels or pulmonary tests within 28 days before treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
A
Amanda Kabetso
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here