Drug intelligence / Profile preview

CLBS03

Development stage
Phase 2
Lead developer
Lisata Therapeutics
Modality
Cell Therapies
Administration
Intravenous
01

Overview

CLBS03 is a personalized autologous cell therapy composed of each patient's own regulatory T cells (Tregs), which are expanded in number and functionally enhanced ex vivo using a proprietary method. The therapeutic rationale is to restore immune balance in autoimmune diseases by increasing the number and activity of functional Tregs, thereby suppressing autoreactive effector T cells that attack self-tissues. In type 1 diabetes mellitus (T1D), this approach aims to protect insulin-producing pancreatic beta cells from immune-mediated destruction. CLBS03 has received FDA Fast Track designation and Orphan Drug status for recent-onset type 1 diabetes with residual beta cell function. The product was developed through collaborations involving Caladrius Biosciences (now Lisata Therapeutics), Becton, Dickinson and Company, Sanford Health, University of California at San Francisco, and Athelos Corporation[1][2][4][5][6][7].

Other names
CD4+CD127lo/-CD25+ polyclonal TregsEx vivo expanded human autologous CD4+CD127lo/-CD25+ polyclonal regulatory T cellsRegulatory T cell therapy - Athelos Corporation/Becton, Dickinson and CompanyRegulatory T lymphocyte cell therapy - AthelosT cell replacement therapy - Athelos Corporation/Becton, Dickinson and CompanyTreg cells - Lisata Therapeutics

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