- Patients with MPD aged 18 years
- Karnofsky performance status 70%
- Patients with malignant pleural disease (MPD), pathologically confirmed at MSKCC, and
defined as one of the following:
1. Malignant pleural mesothelioma - previously treated with at least one prior
2. Non-small cell lung cancer metastatic to the pleurapreviously treated with at
least one prior treatment regimen (chemotherapy or targeted agent) and
documented progression of disease. Patients with disease outside of the pleura
will be discussed among study PI and Co-PIs prior to considered eligible for the
study. Disease outside of the pleura must not require any immediate therapy.
3. Breast cancer metastatic to the pleura previously treated with at least one
prior treatment regimen (chemotherapy or targeted agent) and documented
progression of disease. Patients with disease outside of the pleura will be
discussed among study PI and Co-PIs prior to considered eligible for the study.
Disease outside of the pleura must not require any immediate therapy.
- Expression of mesothelin must be confirmed by meeting one of the following criteria.
1. Mesothelin expression (>10% of the tumor expressing mesothelin) by
immunohistochemical (IHC) analysis
2. Elevated serum SMRP levels (>0.4 nM/L). Patients must have a free flowing
pleural effusion requiring management by placement of a pleural catheter.
Patients with a functional pleural catheter already in place are eligible for
the study, as long as there are no clinical concerns of infection.
- Chemotherapy, targeted therapy (such as a tyrosine kinase inhibitor) or radiotherapy
must have been completed at least 28 days prior to administration of T-cells.
Continuation of hormonal therapy (ie for breast cancer) is acceptable. Prior
immunotherapy with checkpoint blockade (i.e. PD1 inhibitor, PDL1 inhibitor or
CTL4-antagonist or similar agent) must have been completed more than 6 months prior
to the T cell infusion.
- Any major thoracic (thoracotomy with lung or esophageal resection) or abdominal
(laparotomy with organ resection) operation must have occurred at least 28 days
before study enrollment. Patients who have undergone diagnostic VATS or laparoscopy
can be included in the study.
- All acute toxic effects of any previous radiotherapy, chemotherapy, or surgical
procedures must have resolved to grade I or lower according to CTCAE (version 4.0).
- Lab requirements (hematology)
- White blood cell (WBC) count 3000 cells/mm3
- Absolute neutrophil count 1500 neutrophils/mm3
- Platelet count 100,000 platelets/mm3 Lab requirements (serum chemistry)
- Bilirubin <1.5x upper limit of normal (ULN)
- Serum alanine aminotransferase/serum aspartate aminotransferase (ALT/AST) <2.5x 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
- 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
- Any prior history of brain metastases
- Non-small cell lung cancer metastatic to the pleura that extends outside of the
pleura requiring immediate therapy
- Breast cancer metastatic to the pleura that extends outside of the pleura requiring
- Prior history of seizure disorder
- Patients currently receiving treatment for concurrent active malignancy
- 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
- An infection requiring antibiotic treatment within 7 days before 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 before the screening visit
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both