Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in … (NCT05378464) | Clinical Trial Compass
SuspendedPhase 1
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
Stopped: Wait for the DLT period with our current patient and will not be enrolling any more.
United States28 participantsStarted 2022-05-31
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must have a histologically confirmed HER2 positive breast cancer and must be candidates for trastuzumab therapy as per current standard of care. Note: HER2 positive breast cancer is defined by tumor tissue HER2 overexpression and or tumor HER2 amplification per ASCO/CAP criteria.
* Patients will be eligible regardless of ER/PR status which will be determined per 2020 ASCO/CAP guideline and hormonal therapy will be allowed to continue for patients with ER/PR positive disease.
* Must have evaluable disease, defined as at least one lesion that can be accurately measured ≥ 10 mm by standard imaging techniques that can be include but not limited to CT, PET, PET/CT, MRI. Skeletal disease which is measurable by PET/CT or bone scan will also be allowed.
* Must have had disease progression while on trastuzumab for the treatment of HER2+ MBC and received no more than 3 lines of cytotoxic chemotherapy in the setting of metastatic disease.
* ECOG performance status 0 or 1.
* Must have normal organ and marrow function as defined in protocol within 14 days of registration.
* Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan)
* Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum or urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as suspended — do you know why enrollment was paused, and whether it's expected to reopen or if I should look at other options?
2Since this is a Phase 1 trial focused on finding the maximum tolerated dose of the T cell infusion, what does that mean for what's actually known right now about whether this approach is safe or effective for HER2-positive metastatic breast cancer?
3This treatment combines expanded CD4 T cells, a dendritic cell vaccine, pepinemab, and trastuzumab — can you help me understand how complex that regimen would be in terms of appointments, monitoring, and time commitment, and whether that fits my current situation?
4Before considering a trial like this, would it make sense for me to try established HER2-targeted therapies first, and how would that affect my eligibility if this study does reopen?
5Given that my cancer is HER2-positive and metastatic, are there other active trials or standard-of-care options you'd recommend I compare this to while this trial remains suspended?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) of expanded CD4 T cells
Timeframe: Up to 6 months
Trial details
NCT IDNCT05378464
SponsorH. Lee Moffitt Cancer Center and Research Institute