Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma
NCT01722149 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2019-08-07
Summary
MPM patients are not eligible for surgical procedures like decortication or pleuro-pneumectomy and have a median survival of 12 months with palliative chemotherapy. Therefore, new therapeutic approaches are of crucial need in this clinical situation. This is a phase I trial for patients with malignant pleural mesothelioma with pleural effusion testing the safety of a fixed single dose of 1x10e6 adoptively transferred FAP-specific re-directed T cells given directly in the pleural effusion. Lymphocytes will be taken 21 days before transfer from peripheral blood. CD8 positive T cells will be isolated and re-programmed by retroviral transfer of a chimeric antigen receptor (CAR) recognizing FAP which serves as target structure in MPM.
* Trial with immunomodulatory product / biological
Conditions
- Malignant Pleural Mesothelioma
Interventions
- GENETIC
-
Adoptive Transfer of re-directed T cells
Adoptive Transfer of 10e6 re-directed T cells in the pleural effusion
Sponsors & Collaborators
-
University of Zurich
lead OTHER
Principal Investigators
-
Alessandra Curioni, MD · University Hospital Zurich, Division of Oncology
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-19
- Primary Completion
- 2019-03-22
- Completion
- 2019-07-18
Countries
- Switzerland
Study Locations
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