NCT05623488

CAR T Cells in Mesothelin-Expressing Breast Cancer

Phase 1, Adaptive-design Trial of Human Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Breast Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 - Safety and Proof of Concept

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	huCART-meso cells	Autologous T cells lentivirally transduced with chimeric anti-mesothelin immunoreceptor M5 scFv fused to the 4-1BB and CD3ζ signaling domains
DEVICE	Mesothelin Expression Testing	Laboratory Developed Test

Timeline

• Start date: 2023-02-06
• Primary completion: 2025-04-07
• Completion: 2025-04-07
• First posted: 2022-11-21
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study