Breast CancerPhase 1NCT05623488
CAR T Cells in Mesothelin-Expressing Breast Cancer
A Phase 1 study testing huCART-meso cells and Mesothelin Expression Testing in people with Breast Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
Phase 1 - Safety and Proof of Concept Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- huCART-meso cells and Mesothelin Expression Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 7 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function defined as:
- Bilirubin ≤ 2.0 x ULN
- Serum Creatinine ≤ 1.5 x ULN
- ALT/AST ≤ 3 x ULN
- Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air
- Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by echocardiogram
- Male and female patients ≥ 18 years of age.
- Provides written informed consent.
- Subjects of reproductive potential must agree to use acceptable birth control methods
Who cannot join
- 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:
- 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.
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- 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).
- Pregnant or breastfeeding women.
- Any clinically significant pericardial effusion, Class II-IV cardiovascular disability according to the New York Heart Association Classification or other cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study. This determination will be made by a cardiologist if cardiac issues are suspected.
- Patients with significant lung disease as follows:
- Patients with radiographic evidence of greater than lobar lymphangitic pulmonary involvement, greater than lobar bronchial wall thickening suggestive of peribronchial lymphatic disease extension, and/or evidence of extensive bilateral parenchymal metastatic burden.
- Patients with radiographic and/or clinical evidence of active radiation pneumonitis.
- Patients with radiographic evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent (e.g. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc).
- Patients with active central nervous system (CNS) involvement. Screening for this (e.g. lumbar puncture, brain MRI, etc) is not required unless the patient is symptomatic and/or radiographic findings are present.
- Patient has prior/ongoing treatment that will not accommodate washout requirements for immune checkpoint inhibitors as described in the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase 1, Adaptive-design Trial of Human Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Breast Cancer
Phase 1 - Safety and Proof of Concept
Read the detailed description
This is a phase I study to establish the safety and feasibility of lentiviral transduced CAR T cell products in patients with mesothelin expressing breast cancer. This study will be initiated as a single cohort, however the study is designed to allow for additional disease indications and other investigational CAR T cell products to be explored as separate cohorts under this protocol in the future.
Cohort 1: Cohort 1 will evaluate the use of huCART-meso cells delivered intratumorally in patients with locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) which is positive for mesothelin expression by IHC. Eligible subjects must also have an accessible lesion that can be targeted for both intratumoral injection and surgical excision/biopsy by either a surgeon or interventional radiology.
- Conditions
- Breast Cancer
- Being tested
- huCART-meso cells, Mesothelin Expression Testing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
huCART-meso cellsDrug
Autologous T cells lentivirally transduced with chimeric anti-mesothelin immunoreceptor M5 scFv fused to the 4-1BB and CD3ζ signaling domains
Mesothelin Expression TestingDevice
Laboratory Developed Test
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | 3.00 x 10^7 CAR T cells administered intratumoral Receives: Drug: huCART-meso cells; Device: Mesothelin Expression Testing |
| Dose Level -1 | Experimental | 3.00 x 10^6 CAR T cells administered intratumoral Receives: Drug: huCART-meso cells; Device: Mesothelin Expression Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment-limiting toxicities (TLTs)
Measured: 90 days
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0.
Measured: 15 years
Secondary outcomes (7)
Proportion of manufacturing product that do not meet the release criteria.
Measured: 60 days
Proportion of the products that meet the target dose.
Measured: 60 days
Proportion of enrolled subjects that receive study treatment.
Measured: 60 days
Proportion of eligible subjects that receive study treatment
Measured: 60 days
Proportion of subjects for which standard of care treatment is not impacted due to CAR T cell related toxicity.
Measured: 90 days
Kinetics of expansion and persistence of infused cells by flow cytometry.
Measured: 90 days
Kinetics of expansion and persistence of infused cells by quantitative PCR.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start6 Feb 2023
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Why it stopped: Feasibility Concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Tchou, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623488
- Sponsor's protocol ID
- UPCC# 15122, IRB # 852205
- Status last verified
- Aug 2025
- First submitted
- 11 Nov 2022
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Adaptive-design Trial of Human Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Breast Cancer
- ClinicalTrials.gov ID
- NCT05623488
- Acronym / sponsor ID
- UPCC# 15122, IRB # 852205
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility Concerns
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 - Safety and Proof of Concept
Detailed description
This is a phase I study to establish the safety and feasibility of lentiviral transduced CAR T cell products in patients with mesothelin expressing breast cancer. This study will be initiated as a single cohort, however the study is designed to allow for additional disease indications and other investigational CAR T cell products to be explored as separate cohorts under this protocol in the future.
Cohort 1: Cohort 1 will evaluate the use of huCART-meso cells delivered intratumorally in patients with locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) which is positive for mesothelin expression by IHC. Eligible subjects must also have an accessible lesion that can be targeted for both intratumoral injection and surgical excision/biopsy by either a surgeon or interventional radiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: huCART-meso cells, Device: Mesothelin Expression Testing3.00 x 10^7 CAR T cells administered intratumoral |
| Dose Level -1 | Experimental | Drug: huCART-meso cells, Device: Mesothelin Expression Testing3.00 x 10^6 CAR T cells administered intratumoral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with locally advanced unresectable or metastatic triple-negative breast cancer as confirmed by all of the following:
- 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:
Key exclusion criteria (16 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| huCART-meso cellsAutologous T cells lentivirally transduced with chimeric anti-mesothelin immunoreceptor M5 scFv fused to the 4-1BB and CD3ζ signaling domains | Drug | Dose Level -1, Dose Level 1 |
| Mesothelin Expression TestingLaboratory Developed Test | Device | Dose Level -1, Dose Level 1 |
Primary outcome
Occurrence of treatment-limiting toxicities (TLTs)
Time frame: 90 days
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0.
Time frame: 15 years
7 secondary outcomes
Proportion of manufacturing product that do not meet the release criteria.
Time frame: 60 days
Proportion of the products that meet the target dose.
Time frame: 60 days
Proportion of enrolled subjects that receive study treatment.
Time frame: 60 days
Proportion of eligible subjects that receive study treatment
Time frame: 60 days
Proportion of subjects for which standard of care treatment is not impacted due to CAR T cell related toxicity.
Time frame: 90 days
Kinetics of expansion and persistence of infused cells by flow cytometry.
Time frame: 90 days
Kinetics of expansion and persistence of infused cells by quantitative PCR.
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Feasibility Concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Tchou, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing huCART-meso cells and Mesothelin Expression Testing in people with Breast Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Feasibility Concerns). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment-limiting toxicities (TLTs) (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.