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Breast CancerPhase 1NCT02792114

T-Cell Therapy for Advanced Breast Cancer

A Phase 1 study testing Cyclophosphamide, Mesothelin-targeted T cells and AP1903 in people with Breast Cancer and Metastatic HER2-negative Breast, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to test the safety of different doses of specially prepared T cells collected from the blood. The investigators want to find a safe dose of these modified T cells for patients who have metastatic HER2-negative breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cyclophosphamide, Mesothelin-targeted T cells and AP1903
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
7 sitesUnited States
Study dates
Jun 2016to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged ≥18 years with metastatic breast cancer
  • Karnofsky performance status ≥70%
  • Patients with breast cancer that is pathologically confirmed at MSKCC (pathology from outside institutions is acceptable for the screening phase of the protocol) and defined by the following:
  • HER2 negative (in cases of mixed HER2 results, the most recent pathology results considered reflective of the active cancer will be considered)
  • Previously treated with at least 1 chemotherapy regimen for metastatic disease and documented progression
  • Expression of mesothelin must be confirmed by meeting 1 of the following criteria:
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  • Mesothelin expression (>10% of the tumor expressing mesothelin) by IHC
  • Elevated serum SMRP levels (>1.0 nM/L)
  • Presence of measurable or evaluable disease
  • Chemotherapy, targeted therapy (such as a tyrosine kinase inhibitor), or radiotherapy must have been completed at least 14 days before administration of T-cells. Prior immunotherapy with checkpoint blockade (i.e., PD1 inhibitor, PDL1 inhibitor, or CTL4-antagonist or similar agent) must have been completed more than 1 month before the T-cell infusion.
  • Chemotherapy must have been completed at least 7 days prior to leukapheresis
  • Any major operation must have occurred at least 28 days before study enrollment.
  • All acute toxic effects of any previous radiotherapy, chemotherapy, or surgical procedures must have resolved to grade 1 or lower according to CTCAE
  • Lab requirements (hematology):
  • White blood cell (WBC) count ≥3000 cells/mm^3
  • Absolute neutrophil count ≥1500 neutrophils/mm^3
  • Platelet count ≥100,000 platelets/mm^3
  • Lab requirements (serum chemistry):
  • Bilirubin <1.5x upper limit of normal (ULN)
  • Serum alanine aminotransferase/serum aspartate aminotransferase (ALT/AST) <5x ULN
  • Serum creatinine <1.5x ULN or Cr >1.5x ULN, but calculated clearances of >60
  • Negative screen for human immunodeficiency virus (HIV), hepatitis B virus (HBV) antigen, and hepatitis C virus (HCV). If testing was performed during the previous 3 months, there is no need to repeat testing, as long as documentation of results is provided to the study site. Subjects must receive counseling and sign a separate informed consent form for HIV testing.
  • Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the period of drug administration and for 4 weeks after completion of the last administration of the study drug. An effective form of contraception is defined as oral contraceptives plus 1 form of barrier or double-barrier method contraception (condom with spermicide or condom with diaphragm).
  • Subjects must be able to understand the potential risks and benefits of the study and must be able to read and provide written, informed consent for the study.
  • Availability of archival tumor tissues (FFPE tissue block or 10-15 unstained slides)

Who cannot join

  • Untreated or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control); patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met:
  • Presence of measurable or evaluable disease outside of the CNS;
  • Radiographic demonstration of improvement upon completion of CNS- directed therapy and no evidence of interim progression between completion of CNS-directed therapy and the screening radiographic study;
  • Completion of radiotherapy ≥8 weeks prior to the screening radiographic study;
  • Discontinuation of corticosteroids and anticonvulsants ≥4 weeks prior to the screening radiographic study.
  • History of seizure disorder
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  • Patients currently receiving treatment for concurrent active malignancy. Prior immunotherapy with checkpoint blockade (i.e., PD1 inhibitor, PDL1 inhibitor, or CTL4-antagonist or similar agent) must have been completed more than 1 month prior to the T-cell infusion.
  • Autoimmune or antibody-mediated disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis (patients with a history of hypothyroidism will not be excluded)
  • Clinically significant cardiac disease (New York Heart Association class III/IV) or severe debilitating pulmonary disease
  • Pregnant or lactating women
  • Known active infection requiring antibiotics within 7 days of the start of treatment (Day 0)
  • A requirement for daily systemic corticosteroids for any reason or a requirement for other immunosuppressive or immunomodulatory agents. Topical, nasal, and inhaled steroids are permitted.
  • Administration of live, attenuated vaccine within 8 weeks before the start of treatment (Day 0) and throughout the study
  • Any other medical condition that, in the opinion of the PI, may interfere with a subject's participation in or compliance with the study
  • Participation in a therapeutic research study or receipt of an investigational drug within 30 days of T-cell infusion

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Cancer Center (Consent and follow-up only)

    Basking Ridge, New Jersey

  • Memorial Sloan Kettering Cancer Center at Commack (Consent and follow-up only)

    Commack, New York

  • Memorial Sloan Kettering Westchester (Consent and follow-up only)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Consent and follow-up only)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Consent and follow-up only)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Consent and Follow-Up only)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Mesothelin-Specific Chimeric Antigen Receptor-Positive T Cells in Patients With Metastatic Mesothelin-Expressing Breast Cancer

The purpose of this study is to test the safety of different doses of specially prepared T cells collected from the blood. The investigators want to find a safe dose of these modified T cells for patients who have metastatic HER2-negative breast cancer.

Being tested
Cyclophosphamide, Mesothelin-targeted T cells, AP1903
Keywords
T-Cell, Chimeric antigen receptor (CAR), CAR T cells, Triple-negative breast cancer, Immunotherapy T-cell therapy, 16-040, immunotherapy, CAR
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02792114
Study groupRoleWhat they receive
T-cell infusionExperimentalA single blood volume leukapheresis for harvesting of PBMCs will be performed, As the transduced T cells will be frozen, the timing of leukapheresis is not defined \& can vary from patient to patient. Subsequently, a single dose of mesothelin-targeted T cells will be infused via intravenous catheter or central line (i.e., mediport). Patients will be monitored in the hospital and discharged home after a minimum of 48 hours. Patients will be monitored closely as outpatients for the next 2 months. Patients will be followed weekly as outpatients for the first 8 weeks after treatment. All patients will be hydrated intravenously, premedicated with acetaminophen \& diphenhydramine, \& administered cyclophosphamide at 1.5 g/m2 2 to 7 days (Day -7 to Day -2) before administration of mesothelin-targeted T cells.
Receives: Drug: Cyclophosphamide; Biological: Mesothelin-targeted T cells; Drug: AP1903

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated does (MTD)

    We have designed the dose-escalation using a standard 3+3 design. In this design, patients will be treated in sequential groups of 3 to 6 patients per T cell dose. With 4 dose levels, the projected trial size for this study is a minimum of 4 and a maximum of 24 patients.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02792114
Sponsor's protocol ID
16-040
Status last verified
Jul 2026
First submitted
2 Jun 2016
Last updated
16 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cyclophosphamide, Mesothelin-targeted T cells and AP1903 in people with Breast Cancer and Metastatic HER2-negative Breast, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 25 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Maximum tolerated does (MTD) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02792114.

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 16 Jul 2026.

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