T-Cell Therapy for Advanced Breast Cancer (NCT02792114) | Clinical Trial Compass
Active — Not RecruitingPhase 1
T-Cell Therapy for Advanced Breast Cancer
United States186 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* 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:
* 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 requi…