cMet CAR RNA T Cells Targeting Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01837602|
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : October 19, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer Triple Negative Breast Cancer||Biological: cMet RNA CAR T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Autologous cMet Redirected T Cells Administered Intratumorally in Patients With Breast Cancer|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||August 13, 2018|
|Actual Study Completion Date :||August 13, 2018|
Experimental: cMet positive breast cancer patients
Metastatic breast cancer patients with an accessible tumor (cutaneous, subcutaneous, or superficial) and/or a palpable adenopathy/mass, with ≥ 30% tumor cells expressing cMet as demonstrated on immunohistochemical analysis . The intensity for cMet IHC should be greater than or equal to 1+. The targeted tumor must be accessible (i.e. is not near a great vessel or the spinal cord) and can be surgically excised or biopsied.
Biological: cMet RNA CAR T cells
- Number of Serious Adverse Event [ Time Frame: Two years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Step 1 subjects only: metastatic breast cancer patients with an accessible tumor (cutaneous, subcutaneous, or superficial) and/or palpable adenopathy/mass. The targeted tumor is accessible (i.e. is not near a great vessel or the spinal cord) and can be surgically excised or biopsied.
- Step 2 subjects only: Newly diagnosed, operable, triple negative breast cancer, i.e. ER/PR-negative, her2/neu-negative, with tumor size between 2 - 3 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 ≥ 30% tumor cells as demonstrated on immuno-histochemistry analysis of archival slides. The intensity for cMet IHC should be greater than or equal to 1+. Punch biopsy or percutaneous core biopsy may be offered to Cohort 1 patients. To establish eligibility for patients in step 1, archival tumor tissues from any previously biopsied metastatic tumor deposit may be used for IHC staining. The metastatic tumor nodule to be targeted for IT injection may not necessarily be the same as previously biopsied metastatic site.
- Age > 18 years old
- Baseline Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status 0 or 1
- Adequate hematologic function:
WBC > 3.0 Plt > 75,000 Hgb > 10 g/dl Adequate renal function defined as serum creatinine < 1.5 times upper limit of normal
- Adequate hepatic function defined as: Total bilirubin < 1.5 times upper limit of normal, and ALT and AST < 2.5 times upper limit of normal
- Women of child bearing potential must have a negative pregnancy test (blood or urine) and agree to use appropriate contraception from study screen through the duration of the trial. Men must agree to use appropriate contraception from IT injection through the duration of the trial.
- Signed and dated written informed consent.
- Step 1 subjects only: Targeted tumor near a great vessel or spinal cord
- Step 2 subjects only: Women already undergoing neoadjuvant chemotherapy to treat their primary triple negative breast cancer
- Step 1 and 2 subjects:Positive for HIV-1/HIV-2
- Active hepatitis B or hepatitis C infection
- The anticipated use of the following within 2 weeks prior to apheresis and prior to planned IT T-cell injection:
Immunosuppressive drugs Cytotoxic chemotherapy (See Section 5.7 for complete details) Systemic glucocorticoids (steroid prep due to dye allergies prior to staging scans or use in anti-emetic prophylaxis for patients undergoing chemotherapy is allowed) Hematopoietic growth factors Other experimental therapy Note: Step 1 patients receiving non-investigational targeted therapy (lapatinib, trastuzumab, and/or pertuzumab) are eligible provided these medicines are at a stable dose and the patient began taking them more than 30 days prior to the planned IT T-cell injection.
- Anticipated use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before the planned IT T-cell injection RETIRED AS OF PROTOCOL VERSION 11
- Pregnant women or nursing mothers
- History of alcohol abuse or illicit drug use within 12 months of IT T-cell injection
- 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 that in the Investigator's opinion would jeopardize protocol compliance or compromise the patient's ability to give informed consent.
- Prior MI ascertained from medical history and review of systems
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837602
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Julia Tchou, MD||Abramson Cancer Center at Penn Medicine|
|Responsible Party:||University of Pennsylvania|
|Other Study ID Numbers:||
UPCC 13111, 813858
|First Posted:||April 23, 2013 Key Record Dates|
|Last Update Posted:||October 19, 2018|
|Last Verified:||October 2018|
refractory to at least one standard therapy
with operable triple negative breast cancer
Triple Negative Breast Neoplasms
Neoplasms by Site