Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)

Phase 2 Completed 113 enrolled Lisata Therapeutics, Inc. California Institute for Regenerative Medicine (CIRM) · collab Sanford Health · collab

RandomizedFactorialQuadruple-blindTreatment

Summary

This clinical trial will explore the safety and effect of autologous ex vivo expanded polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or low dose) or placebo.

Timeline

Start: 2016-02
Primary completion: 2019-03
Completion: 2020-01

Outcome

Missed primary endpoint

paper The single doses of expTregs were safe but did not prevent decline in residual β cell function over 1 year compared to placebo (P = 0.94 low dose, P = 0.21 high dose) PMID 38718135 ↗

Publications

Bender C, Wiedeman AE, Hu A, Ylescupidez A, Sietsema WK, Herold KC, Griffin KJ, Gitelman SE, Long SA; T-Rex Study Groupdagger; T-Rex Clinical Study Group. A phase 2 randomized trial with autologous polyclonal expanded regulatory T cells in children with new-onset type 1 diabetes. Sci Transl Med. 2024 May 8;16(746):eadn2404. doi: 10.1126/scitranslmed.adn2404. Epub 2024 May 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CLBS03	Cell therapy	1e+06 cells/kg	Other
Subject	CLBS03	Cell therapy	2e+07 cells/kg	Other