University of Virginia
The purpose of this study is to understand the safety and estimate the efficacy of anti-CD3 x anti-HER2 bispecific antibody (HER2Bi) armed fresh peripheral blood mononuclear cells (HER2 FPBMC) for patients with metastatic breast or prostate cancer. Participants receive 5 weekly doses of CD33 FPBMC by intravenous infusion followed by 4 infusions every other week.
Once subjects are determined to be eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. The T cells in the mononuclear cells are coated with bispecific antibody to activate the T cells and the mononuclear cells are re-infused into the patients so the T cells can multiply and kill cancer cells. At least 72 hours after the leukapheresis procedure, study treatment will start. After 5 HER2 FPBMC infusions, participants will have another leukapheresis procedure. Before, throughout and following study treatment, research blood will be collected to better understand im…
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age ≥ 18 years at the time of signing informed consent 4. Expected survival ≥ 3 months in the judgment of the investigator 5. ECOG PS 0-1 6. Adequate Organ Function per the following criteria (within 10 days of study registration): * Absolute lymphocyte count ≥ 400/mm3 * Absolute neutrophil count ≥ 1000/mm3 * Platelets ≥ 75,000/mm3 * Hemoglobin ≥ 9g/dL * Serum creatinine \< 2.0 mg/dL OR measured o…
Participants will receive 5 weekly infusions of HER2 FPBMC infusions followed by 4 additional infusions every other week.
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