Trials / Completed
CompletedNCT02159716
CART-meso in Mesothelin Expressing Cancers
Phase I Study of Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Cancers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Metastatic Pancreatic (Ductal) Adenocarcinoma
- Epithelial Ovarian Cancer
- Malignant Epithelial Pleural Mesothelioma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CART-meso | CART-meso are autologous T cells lentivirally transduced with chimeric anti-mesothelin immunoreceptor SS1 fused to the 4-1BB and CD3ζ signaling domains. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2014-06-10
- Last updated
- 2025-06-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02159716. Inclusion in this directory is not an endorsement.