Actively Recruiting
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
28
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
V
Vaccinex Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.
CONDITIONS
Official Title
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed HER2 positive breast cancer and candidates for trastuzumab therapy
- Eligible regardless of ER/PR status; hormonal therapy allowed for ER/PR positive disease
- At least one measurable lesion (≥10 mm) by standard imaging techniques
- Disease progression while on trastuzumab for HER2 positive metastatic breast cancer
- Received no more than 3 lines of cytotoxic chemotherapy for metastatic disease
- ECOG performance status 0 or 1
- Normal organ and marrow function within 14 days of registration
- Left ventricular ejection fraction above institutional lower limit of normal
- Female patients of childbearing potential must use dual contraception methods and have a negative pregnancy test
- Male patients must use effective barrier contraception if sexually active with female of childbearing potential
- Postmenopausal women must be amenorrheic for at least 12 months naturally or surgically sterile
- Ability to understand and willingness to sign informed consent
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Chemotherapy or radiotherapy within 14 days prior to starting protocol therapy
- Receiving other investigational agents within 14 days or 5 half-lives before protocol therapy
- Uncontrolled brain metastases or leptomeningeal disease
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations limiting compliance
- Active autoimmune disease or history that may recur and affect vital organs or require immune suppressive treatment including prolonged corticosteroids
- Pregnant or nursing females
- Second invasive malignancy requiring active treatment
- Positive for HIV/AIDS
- Positive for Hepatitis B or C indicating acute or chronic infection
- Received live attenuated vaccine within 30 days of registration
- Unable to comply with treatment schedule and study procedures
- Previously treated with any form of adoptive cell transfer therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
K
Kim Sprenger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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