Phase 1 - Safety and Proof of Concept
This is a phase I study to establish the safety and feasibility of lentiviral transduced CAR T cell products in patients with mesothelin expressing breast cancer. This study will be initiated as a single cohort, however the study is designed to allow for additional disease indications and other investigational CAR T cell products to be explored as separate cohorts under this protocol in the future. Cohort 1: Cohort 1 will evaluate the use of huCART-meso cells delivered intratumorally in patients with locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) which is positive for mesothelin expression by IHC. Eligible subjects must also have an accessible lesion that can be targeted for both intratumoral injection and surgical excision/biopsy by either a surgeon or interventional radiology.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Autologous T cells lentivirally transduced with chimeric anti-mesothelin immunoreceptor M5 scFv fused to the 4-1BB and CD3ζ signaling domains
Laboratory Developed Test
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Occurrence of treatment-limiting toxicities (TLTs)
Time frame: 90 days
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0.
Time frame: 15 years
Proportion of manufacturing product that do not meet the release criteria.
Time frame: 60 days
Proportion of the products that meet the target dose.
Time frame: 60 days
Proportion of enrolled subjects that receive study treatment.
Time frame: 60 days
Proportion of eligible subjects that receive study treatment
Time frame: 60 days
Proportion of subjects for which standard of care treatment is not impacted due to CAR T cell related toxicity.
Time frame: 90 days
Kinetics of expansion and persistence of infused cells by flow cytometry.
Time frame: 90 days
Kinetics of expansion and persistence of infused cells by quantitative PCR.
Time frame: 90 days
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