CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases

Sponsor
Nanjing Bioheng Biotech Co., Ltd.
Study ID
NCT07596680
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • ANCA Associated Vasculitis
  • Idiopathic Inflammatory Myopathies
  • SLE - Systemic Lupus Erythematosus
  • Sjögren Syndrome
  • Systemic Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • RD06-05 CAR-T Cell Injection — DRUG
    CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

Study Details

This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. The enrolled population consists of patients with active autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), Sjögren's syndrome (SS), among others. The CAR-T cell dose used in this study is 6×10⁶ CAR⁺ T cells/kg. Six subjects will be enrolled for each indication, with a total of 30 subjects to be enrolled.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RD06-05

Primary Outcome Measure

SLE (systemic lupus erythematosus) [ Time Frame: 2 years ]

Central Contacts

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