Clinical Trial of Autologous cMet Redirected T Cells Administered Intratumorally in Patients With Breast Cancer
- Step 1 subjects only: metastatic breast patients refractory to at least one standard
therapy, with easily accessible metastatic deposits (cutaneous, subcutaneous, or
superficial and/or palpable adenopathy/mass).
- Step 2 subjects only: Newly diagnosed, operable, triple negative breast cancer, i.e.
ER/PRnegative, her2/neu-negative, with tumor size between between 2- 5 cm (T2) as
measured by either clinical breast exam, mammogram, ultrasound or MRI, with or
without ipsilateral axilla node involvement (N0 or N1).
- cMet expression in greater than or equal to 30% tumor cells as demonstrated on
immuno-histochemistry analysis of archival slides. Punch biopsy or percutaneous core
biopsy may be offered to Cohort 1 patients.
- Age greater than or equal to 18 years old
- Baseline Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status 0 or 1
- Life expectancy greater than 6 months
- Adequate hematologic function established within 14 days before treatment:
- WBC greater than or equal to 3.0
- Plt greater than or equal to 75,000
- Hgb greater than or equal to 10 g/dl
- dequate renal function established within 14 days before treatment defined as serum
creatinine less than 1.5 times upper limit of normal
- Adequate hepatic function established within 14 days before treatment defined as:
- Total bilirubin less than 1.5 times upper limit of normal, and
- ALT and AST less than 2.5 times upper limit of normal
- Women of child bearing potential must have a negative pregnancy test (blood or urine)
within 14 days before treatment and agree to use appropriate contraception from study
screen through the duration of the trial. Men must agree to use appropriate
contraception from study screen through the duration of the trial.
- Tumor staging by standard imaging within the past 30 days (Step 1 subjects only).
- Signed and dated written informed consent.
- Step 1 subjects only:
- Currently taking cytotoxic chemotherapy; however, patients receiving
non-investigational hormone therapy, lapatinib, and/or trastuzumab are eligible
provided these medicines are at a stable dose and were begun more than 30 days prior
to the first IT injection
- Metastatic deposits near a great vessel or spinal cord
- Step 2 subjects only:
- Prior therapy for breast cancer
- Women already undergoing neoadjuvant chemotherapy to treat their primary triple
negative breast cancer
- Step 1 and 2 subjects:
- Positivity for HIV-1/HIV-2, Hepatitis B virus, and Hepatitis C virus active infection
- The use of the following within 30 days before treatment:
- Immunosuppressive drugs
- Systemic glucocorticoids
- Hematopoietic growth factors
- Experimental therapy
- Use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before
- Pregnant women or nursing mothers
- History of alcohol abuse or illicit drug use within 12 months of study initiation
- Clinically significant comorbid disease or other underlying condition, including
major autoimmune disorders that would contraindicate study therapy or confuse
interpretation of study results
- Significant psychiatric disorder and any other reason in the Investigators opinion
that would jeopardize protocol compliance or compromise the patients ability to give
- Prior MI ascertained from medical history and review of systems