CAR T Cells in Mesothelin-Expressing Breast Cancer (NCT05623488) | Clinical Trial Compass
TerminatedPhase 1
CAR T Cells in Mesothelin-Expressing Breast Cancer
Stopped: Feasibility Concerns
United States2 participantsStarted 2023-02-06
Plain-language summary
Phase 1 - Safety and Proof of Concept
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
. Patients with locally advanced unresectable or metastatic triple-negative breast cancer as confirmed by all of the following:
. ER-negative or low-ER positive (≤ 10% by IHC)
. PR-negative or low-PR positive (≤ 10% by IHC)
. HER2 negative by IHC/FISH
. Patients with an accessible lesion that can be targeted for both intratumoral injection and surgical excision/biopsy by either a surgeon or interventional radiology.
. Confirmed tumor mesothelin expression by ≥ 10% of malignant cells by IHC.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Adequate organ and bone marrow function defined as:
Exclusion criteria
. Active invasive cancer other than the study-targeted malignancy.
. Evidence of active hepatitis B or hepatitis C. The following would not qualify as an active infection, thus would not exclude the subject from participating:
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Occurrence of treatment-limiting toxicities (TLTs)
Timeframe: 90 days
2
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0.
. Positive HBV serology with undetectable viral load and ongoing antiviral prophylaxis for potential HBV reactivation.
. Positive HCV serology with quantitative PCR for plasma HCV RNA below the lower limit of detection, with or without concurrent antiviral HCV treatment.
. Patients with ongoing or active infection.
. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10 mg/day of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
. Planned concurrent treatment with systemic high dose corticosteroids. Patients may be on a stable low dose of steroids (≤ 10mg daily equivalent of prednisone). Use of inhaled or topical steroids is allowable.
. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).