A Study of BEN301 Injection in the Treatment of Autoimmune Diseases

StatusRecruiting
PhaseEarly Phase 1
Started

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Trial flagged as At Risk
Enrollment reduced 92% 24 → 2 participants
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Record History

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  1. Enrollment reduced: 24 → 2 participants Show 6 more changesShow less
    • Recruitment opened
    • Primary and study completion moved earlier from Feb 28, 2029 to Apr 30, 2027
    • Start date changed from estimate of Mar 25, 2026 to Apr 1, 2026
    • Eligibility criteria expanded, about 83 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Site details revised at 2 of 2 sites
  2. Study sites: 1 to 2v3
  3. Secondary endpoints: details revised at 3 of 5 entries
    • Study title shortened, about 2 words
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 BEN301Injection 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.
Trial Details
NCT Number NCT07502859
Lead Sponsor Beijing Boren Hospital
Conditions
(from sponsor)		 SSC RA SS IIM
Enrollment 2 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov