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news.Cytheris, the Centre Léon Bérard (Lyon) and ImmunID Technologies SAS (Grenoble) have initiated a Phase IIa clinical trial to evaluate multiple combinations of Cytheris’ investigational multifunctional recombinant human interleukin-7 (CYT107) and a chemotherapeutic agent XELODA (capecitabine, Roche/Genentech) in the treatment of metastatic breast cancer.
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CYT107 is a critical immune-modulator for immune T-cell recovery and enhancement.
The study, known as ELYPSE-7, is a randomised, monocentric, double-blind Phase IIa study evaluating the impact of IL-7 immunotherapy on CD4 lymphopenia and TCR repertoire diversity, risks of severe haematological toxicity and tumor progression in metastatic breast cancer patients.
Twenty-four patients will be enrolled at a single center (Centre Léon Bérard, Lyon, France).
The duration of the investigation for each patient will include a study drug treatment period of at least 12 weeks (including 3 x 3-week cycles of chemotherapy) and a follow-up period for a maximum of one year (or until disease progression).
The primary endpoint of the study is the evolution of patient CD4 counts from D0 to W12 with repeated measures at D0, W3, W9, and W12.
Secondary endpoints include the impact of CYT107 treatment on the incidence of severe hematological toxicity as indicated by the number of patients experiencing any type of hematological Adverse Event (including anemia, thrombopenia, lymphopenia, or neutropenia) of Grade = 3 from D0 to W12.
The Université Claude Bernard, Lyon, Medicine professor and the European Organization for Research and Treatment of Cancer (EORTC) current president Jean-Yves Blay said the outcome of the ELYPSE-7 study is expected to have significant implications for overall survival and tumor progression in patients with advanced cancers, including ovarian cancer, metastatic breast cancer, non- Hodgkin lymphoma, and sarcoma.