CATS: Crohn's and Tr1 cells Study
CATS (Crohn's and Tr1 cells Study) is a 12 week, multicenter, open, uncontrolled, dose ranging, phase I/IIa clinical study to evaluate the safety and efficacy of OvaSave® in patients with chronic active Crohn's disease. • The primary study objective is:
To evaluate the safety and tolerability of OvaSave®, antigen-specific autologous Tr1 cells, at escalating doses, when administered intravenously as a single administration to patients with chronic active Crohn's Disease (CACD). • The secondary study objectives are:
- The assessment of the efficacy of OvaSave® at escalating doses through clinical, biological parameters in patients with CACD.
- The determination of the dose(s) presenting the most acceptable risk/benefit ratio in view of the future clinical studies. CATS represents a first antigen-specific
autologous Tr1 cells injection trial in humans.
Thus for safety reasons, we decided to target only severe patients who are refractory to all kinds of treatments including TNF-alpha blocking agents. Also we decided to ensure complete security for the first patients to be injected with a new cell therapy: a first dose of 106 cells will be used. Then, incremental doses will be injected to assess efficacy aspects of the treatment. | 
