Caladrius Biosciences have announced that the first subject has been treated in The Sanford Project: T-Rex Study, a phase 2 clinical trial for the T-regulatory (Treg) cell-based therapy (CLBS03), Caladrius’ candidate for the treatment of recent-onset type 1 diabetes (T1D).
Tregs regulate immune activity by moderating T effector cell activity which, in the case of T1D, uncontrollably attack insulin-producing pancreatic beta cells.
The trial will evaluate the safety and efficacy of CLBS03, with 111 subjects aged between 12 and 17 expected to enrol. The subjects will be randomly split into three groups: high dose, low dose and placebo. Evaluation will occur over the course of 2 years, with key endpoints being the standard medical and regulatory endpoints for a typical type 1 diabetes trial.
“The initiation of enrolment of this trial marks an important milestone for our investigational type 1 diabetes program and moves this program into the clinical development stage,” said David J Mazzo, CEO of Caladrius.
Source: Caladrius Biosciences Announces First Subject Treated in CLBS03 Type 1 Diabetes Phase 2 Trial; Press Release