RecruitingPhase 1 / Phase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants receive 5 weekly doses of CD33 FPBMC by intravenous infusion followed by 4 infusions every other week."
  • "After 5 HER2 FPBMC infusions, participants will have another leukapheresis procedure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of HER2 FPBMC, a treatment made from blood immune cells with attached antibodies, and how well it may work. It is for adults with breast or prostate cancer that has spread to other parts of the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, sign a consent form, and agree to follow study visits, procedures, and lifestyle rules.
  • Be expected to live at least 3 months and be able to do most daily activities with little or no help.
  • Have blood counts and kidney and liver tests that meet study requirements within 10 days before signing up.
  • Have breast or prostate cancer confirmed by testing a tissue or cell sample.
  • Have at least one area of cancer spread seen on a CT, MRI, or bone scan within 28 days before signing up.
  • For prostate cancer: have cancer that is growing despite treatment to lower testosterone, a testosterone level below 50 ng/dL, and cancer that worsened after at least one newer hormone-blocking drug.
  • For breast cancer: have previously treated cancer that has spread and can be checked using the study’s standard rules. It must have worsened after at least two hormone or targeted treatments, or two courses of chemotherapy.
  • For HER2-positive breast cancer: cancer must have worsened on at least one HER2-targeted treatment, or that treatment caused side effects you could not tolerate.

Who can't join

  • Be pregnant or breastfeeding. A negative pregnancy test is required within 7 days before signing up.
  • Have a heart attack within the past year, an older heart attack needing nitroglycerin more than once a week, or certain serious heart problems.
  • Have a weak immune system; recent ongoing steroid or other immune-suppressing treatment; or an autoimmune disease, where the body attacks itself, needing whole-body treatment in the past 2 years. Hormone replacement treatment does not count.
  • Have active liver disease, HIV, active hepatitis B or C, a history of active tuberculosis, or an infection needing whole-body treatment.
  • Have a serious wound that will not heal, an ulcer, broken bone, major surgery, open biopsy, or major injury within 28 days; active bleeding or high bleeding risk; or another serious uncontrolled illness. Blood thinners are allowed.
  • Have a live vaccine within 30 days, an experimental drug within 3 weeks, or another active cancer needing whole-body treatment, with exceptions for certain skin cancers and treated cervical cancer.
  • Have a BRCA1 or BRCA2 gene change with an approved targeted treatment available, unless that treatment is unsuitable, is refused, or has already failed. For prostate cancer, have a small-cell neuroendocrine type. For breast cancer, have cancer causing an immediate threat to organ function or life.
  • Have another condition, treatment, or test result that could make the study unsafe or affect its results, or be unable to follow study requirements, as judged by the study team.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 or calculated creatinine clearance ≥ 50 ml/mm * Total bilirubin ≤ mg/dL * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 5.0 times normal 7. Agreement to adhere to Lifestyle Considerations throughout study duration 8. 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 ng/dL during screening. iv. Must have progressed on at least one prior ARPI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide). v. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration. b. Breast Cancer i. Histological and/or cytological confirmation of invasive breast cancer. ii. Participants must have previously treated metastatic breast cancer at screening. Metastatic breast cancer must be evaluable by RECIST 1.1 criteria. iii. Must have progressed on at least two prior endocrine or targeted therapies or at least two lines of cytotoxic chemotherapy. If HER2 positive, then must have progressed on or been intolerant of at least one HER2 targeted therapy. iv. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration. Exclusion Criteria: 1. Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation 2. History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively requiring nitroglycerine more than once per week 3. Inadequate cardiac function, as defined as any of the following: * Uncontrolled angina or severe ventricular arrhythmias * Clinically significant pericardial disease * History of myocardial infarction (MI) in the last year before registration * Class 3 or higher New York Heart Association Congestive Heart Failure 4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 5. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration 6. Active liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis 7. Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus. 8. Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed) 9. Has an active infection requiring systemic therapy 10. A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy 11. Has a known history of active TB (Bacillus Tuberculosis) 12. Has received a live vaccine within 30 days of study registration. 13. Treatment with any investigational agent within 3 weeks prior to study registration 14. Active second malignancy requiring systemic treatment. Exceptions include basal cell carcinoma of the skin, treated cervical cancer, and squamous cell carcinoma of the skin 15. Has active autoimmune disease that has required systemic treatment in the 2 years prior to registration (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. 17. Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant Additional Exclusion Criteria for Patients with Prostate Cancer: 1. Has small cell neuroendocrine carcinoma (pure or mixed) on prior or current histologic evaluation of primary or metastatic lesions 2. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible. Additional Exclusion Criteria for Patients with Breast Cancer: 1. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible. 2. Participants in visceral crisis at risk of immediately life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial, and peritoneal), pulmonary lymphangitis, or liver involvement \> 50%.

Study sites (1)

VA