Phase I Study for the Adoptive Transfer of Re-directed FAP-specific T Cells in the Pleural Effusion of Patients With Malignant Pleural Mesothelioma.
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
until 35 days after transfer of re-directed T cells
Christoph Renner, Prof MD
University Hospital Zurich, Division of Immunology