drugset
drugset / Trial / NCT02159716

CART-meso in Mesothelin Expressing Cancers

NCT02159716 ↗

Phase 1 Completed 19 enrolled University of Pennsylvania
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Phase I study to establish safety and feasibility of intravenously administered lentiviral transduced CART-meso cells administered with and without cyclophosphamide in a 3+3 dose escalation design in patients with metastatic pancreatic cancer, serous epithelial ovarian cancer, or pleural mesothelioma. Dose: 1-3xE7 /mE2 (Cohort 1 and 2) and 1-3xE8 /mE2 (Cohort 3 and 4 ) CAR+ T cells by intravenous route. In the event of 2 DLTs at each dose level, we will dose deescalate by 10-fold.

Timeline

Start
2014-06
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject CART-meso Cell therapy 1e+07 cells Intravenous
Subject CART-meso Cell therapy 1e+08 cells Intravenous

Indications

malignant epithelial tumor of ovary malignant pleural mesothelioma pancreatic ductal adenocarcinoma