A Randomised, Multicentric, Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients
A key secondary objective is to determine if CYT107 treatment enables to reduce the
incidence of severe haematological toxicity (any type of haematological toxicity Grade ≥ 3)
Other secondary objectives are to assess the impact of CYT107 treatment on the following
- Overall incidence of side effects (any type any grade)
- Progression-free survival (PFS)
- Compliance to chemotherapy regimen (dose intensity, number of chemotherapy cycles).
- CD4 lymphopenia over the study period
Exploratory biological markers
A series of biomarkers analyses will be performed to evaluate if CYT107 treatment will:
- selectively stimulate the proliferation and activation of peripheral immune subsets
(analysis of phenotype and activation status of peripheral immune e sub-populations)
- selectively improve the functional response of T cells, DC subsets and NK cells.
- is able to revert tolerogenic immune burden to increase specific anti-tumor response
(measure of antigen specific CD8 response, measure of cytokine plasmatic levels)
- enable to increase TCR diversity (analysis of combinatorial diversity).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count
Evolution of CD4 count from Day 0 to Week 11 with repeated measures from D0 to W12 (D0, D21, D57, D78).
after 11 weeks of treatment
Isabelle Ray Coquart
Centre Léon Bérard, Lyon
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)