A Study of BEN301 Injection in theTreatment of Autoimmune Diseases

The study aims to investigate the safety, tolerability, and preliminary clinical efficacy of BEN301 Injection in patients with autoimmune diseases. In patients with autoimmune diseases, Treg cells are typically deficient or dysfunctional. CAR-Treg cell therapy represents a promising strategy for the treatment of autoimmune diseases and may be applicable to a broad spectrum of autoimmune conditions. Preclinical studies have shown that BEN301 Injection not only effectively suppresses the aberrant activation of T and B cells in SLE models, but also significantly reduces total lgG secretion and the production of SLE-specific autoantibodies, particularly anti-double-stranded DNA (dsDNA) antibodies. Moreover, no significant treatment-related toxicities were observed. Treg cell therapy has already demonstrated favorable efficacy in multiple indications, including organ transplantation and autoimmune diseases, with a well-established safety and tolerability profile. Meanwhile, CAR-Treg cell therapy has been actively explored in various autoimmune conditions; several products have shown therapeutic potential, and some patients have already benefited from treatment. These findings highlight the promising prospects of CAR-Treg cell therapy in the management of autoimmune diseases.

NCT Number	NCT07527936
Lead Sponsor	RenJi Hospital
Conditions	Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA), Sjogren's Syndrome (SS), Idiopathic Inflammatory Myopathies(IIM)
Enrollment	24 participants
Start Date	2026-04-20
Primary Completion	2028-08-31 (estimated)
Study Completion	2029-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-06-04