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A Study of BEN301 Injection in theTreatment of Autoimmune Diseases

NCT07527936 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-14

No results posted yet for this study

Summary

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.

Conditions

  • Systemic Sclerosis (SSc)
  • Rheumatoid Arthritis (RA)
  • Sjogren's Syndrome (SS)
  • Idiopathic Inflammatory Myopathies(IIM)

Interventions

BIOLOGICAL

Single administration of 1x10^8 viable CD4+ CAR+ Foxp3+ cells.

Lymphodepletion is generally not required; however, if Treg expansion issuboptimal, lymphodepletion may be administered as needed, or low-dose IL-2 may be combined. The recommended lymphodepletion regimens include: Cyclophosphamide monotherapy (CTX 900-1000 mg/m2 on day -3,or CTX 300 mg/m\^2 from day -5 to day -3); or cyclophosphamide combined with fludarabine (12.5-25 mg/m\^2 from day -5 to day -3); - or low-dose IL-2 administered after cell infusion.

BIOLOGICAL

Single administration of 3x10^8 viable CD4+ CAR+ Foxp3+ cells.

Lymphodepletion is generally not required; however, if Treg expansion issuboptimal, lymphodepletion may be administered as needed, or low-dose IL-2 may be combined. The recommended lymphodepletion regimens include: Cyclophosphamide monotherapy (CTX 900-1000 mg/m2 on day -3,or CTX 300 mg/m\^2 from day -5 to day -3); or cyclophosphamide combined with fludarabine (12.5-25 mg/m\^2 from day -5 to day -3); - or low-dose IL-2 administered after cell infusion.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2028-08-31
Completion
2029-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07527936 on ClinicalTrials.gov