HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006)
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)
About This Trial
- This study is testing an experimental treatment that uses specially targeted immune cells to help the body recognize and attack cancer.
- It is for adults with advanced prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone therapies.
- If you take part, you will receive the treatment through an IV infusion once a week for five weeks, followed by four additional infusions given every two weeks.
- Before considering this trial, you should know that you must be in relatively good daily health with functioning organs, and you cannot participate if you have serious heart conditions, active infections, or severe autoimmune diseases.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: All
- Who This Trial is For: This study is testing an experimental treatment that uses specially targeted immune cells to help the body recognize and attack cancer.
Study Details
- Start Date: June 2026
- Lead Sponsor: University of Virginia
Full Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 18 years at the time of signing informed consent
- Expected survival ≥ 3 months in the judgment of the investigator
- ECOG PS 0-1
- 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 or calculated creatinine clearance ≥ 50 ml/mm
- Total bilirubin ≤ mg/dL
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 5.0 times normal
- Agreement to adhere to Lifestyle Considerations throughout study duration
- A diagnosis of either of the following: a. Prostate Cancer: i. Histological and/or cytological confirmation of prostate adenocarcinoma. ii. Participants must have progressive mCRPC at screening iii. Serum testosterone levels 50%.
Treatments
- Drug: HER2 FPBMC