Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma
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|ClinicalTrials.gov Identifier: NCT01722149|
Recruitment Status : Recruiting
First Posted : November 6, 2012
Last Update Posted : January 2, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Genetic: Adoptive Transfer of re-directed T cells||Phase 1|
This is a phase I trial for patients with malignant pleural mesothelioma. A fixed single dose of adoptively transferred FAP-specific CD8 positive re-directed T cells will be given in the pleural effusion.
Three patients who are at the time point of screening not operable will be treated with re-directed T cells administered into the pleural effusion after completion of 3 cycles of palliative chemotherapy. In the case of one AE grade III/IV or one SAE - and the occurrence of DLT both judged to be treatment related by an independent safety monitoring board - the patient number will be expanded to 6 patients. The study will be stopped if one additional DLT occurs also judged to be treatment related.
Patients will be treated with 1x10e6 re-directed FAP-specific T cells injected in the pleural effusion. The study ends 35 days after adoptive T cell transfer. Re-directed FAP-specific T cells will be administered at day 0 (day 14 of the third cycle of palliative chemotherapy). The study is designed to demonstrate safety of 1x10e6 re-directed FAP-specific T cells. The next patient will be enrolled earliest, when the previous patient completed day +14 and the safety monitoring board has not declared any DLTs. The palliative chemotherapy is not part of the study protocol.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Adoptive Transfer of re-directed FAP-specific T cells|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study for the Adoptive Transfer of Re-directed FAP-specific T Cells in the Pleural Effusion of Patients With Malignant Pleural Mesothelioma.|
|Actual Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Adoptive Transfer of re-directed T cells
Adoptive Transfer of re-directed FAP specific T cells in the pleural effusion
Genetic: Adoptive Transfer of re-directed T cells
Adoptive Transfer of 10e6 re-directed T cells in the pleural effusion
- Safety [ Time Frame: until 35 days after transfer of re-directed T cells ]Incidence and severity of treatment-related laboratory abnormalities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version v4.03 criteria as grade III-IV. In the case of one AE grade III/IV or one SAE the safety monitoring board will judge whether the case is treatment related and whether it have to be counted as DLT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722149
|Contact: Alessandra Curioni, MDfirstname.lastname@example.org|
|Contact: Helga Bachmann, Study Coordinationemail@example.com|
|University Hospital Zurich, Division of Oncology||Recruiting|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Alessandra Curioni, MD||University Hospital Zurich, Division of Oncology|