Date: 2016-02-12
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Caladrius Biosciences (USA - CA)
Product: CLBS03
Action
mechanism: cell therapy/immunotherapy product. CLBS03 is a personalized, autologous medicine consisting of each patient’s own Tregs, which have been expanded in number and functionally enhanced by a proprietary method developed by a collaboration between PCT and the University of California, San Francisco. The program is supported by promising published early clinical work conducted by respected leaders in the area of T regulatory cell science. The scientific basis for treating T1D with CLBS03 derives from the use of Tregs to treat autoimmune diseases caused by T-cell imbalances in an individual’s immune system. This innovative approach seeks to restore immune balance by enhancing Treg cell number and function. Tregs are a natural part of the human immune system and regulate the activity of T effector cells, which are responsible for protecting the body from viruses and other foreign antigens. When Tregs function properly, only harmful foreign materials are attacked by T effector cells. In autoimmune diseases, deficient Treg activity permits the T effector cells to attack the body’s own beneficial cells, for example, insulin-producing pancreatic beta cells in the case of T1D.
Disease: diabetes
Therapeutic area: Metabolic diseases
Country: USA
Trial
details: The Sanford Project: T-Rex Study is a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for T1D with residual beta cell function in approximately 111 subjects age 12 to 17 in two cohorts (18 subjects followed by 93 subjects). The study is being conducted in collaboration with Sanford Research, a subsidiary of Sanford Health. Subjects will be randomized into one of three groups and will receive either a high dose of CLBS03, a low dose of CLBS03 or placebo. The key endpoints for the trial are the standard medical and regulatory endpoints for a T1D trial and include preservation of C-peptide, an accepted measure for pancreatic beta cell function; insulin use; severe hypoglycemic episodes; and glucose and hemoglobin A1c levels. (NCT02691247)
Latest
news: * On February 12, 2016, a Phase 2 trial sponsored by Caladrius Biosciences was published on the NIH website ClinicalTrials.gov for CLBS03 and is currently recruiting participants.
