Phase I/II Study of Anti-CD3 x Anti-HER2 Bispecific Antibody (HER2Bi) Armed Fresh Peripheral Blood Mononuclear Cells (HER2 FPBMC) in Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Breast Cancer (MBC)
University of Virginia
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugHER2 FPBMC
Participants will receive 5 weekly infusions of HER2 FPBMC infusions followed by 4 additional infusions every other week.
Location
- University of VirginiaCharlottesville, Virginia