The Food and Drug Administration (FDA) has granted Fast Track designation to Caladrius Biosciences’ product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) for the treatment of Type 1 diabetes mellitus (T1DM).

CLBS03 is currently being investigated in a Phase 2 clinical trial, The Sanford Project: T-Rex Study, in collaboration with Sanford Health. The study is a prospective, randomized, placebo-controlled, double-blind trial evaluating the efficacy and safety of CLBS03 in approximately 111 T1DM patients aged 12-17 years with residual beta cell function. The key study endpoints include preservation of C-peptide (an accepted measure for pancreatic beta cell function), insulin use, severe hypoglycemic episodes, and glucose and hemoglobin A1c levels. 

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CLBS03 is a personalized, autologous therapy consisting of each patient’s own expanded and functionally enhanced Tregs, regulator of T effector cell activity. The scientific basis for treating T1DM with CLBS03 derives from the use of Tregs to treat autoimmune diseases caused by an individual’s immune system imbalances. By enhancing Treg cell number and function, T effector cells are properly regulated and the attack to the body’s own beneficial cells (eg, insulin-producing pancreatic beta cells in T1DM) is prevented. In previous Phase 1 studies, data showed that treatment with expanded autologous Tregs preserved pancreatic beta cell function and reduced exogenous insulin requirement in the majority of patients treated.

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