Actively Recruiting
Study of RD06-05 Anti-CD19BCMA Universal CAR-T Cell Therapy for Autoimmune Diseases Evaluating Safety, Effectiveness, and Cell Behavior
Led by Nanjing Bioheng Biotech Co., Ltd. · Updated on 2026-08-03
96
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new anti-CD19BCMA universal CAR-T cell therapy called RD06-05 in adults with various autoimmune diseases, including systemic lupus erythematosus SLE, lupus nephritis LN, ANCA-associated vasculitis AAV, anti-GBM disease, membranous nephropathy MN, systemic sclerosis SSc, idiopathic inflammatory myopathy IIM, and IgA nephropathy. This early phase 1, open-label, single-arm study aims to explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of this investigational cell therapy. Participants will receive the RD06-05 CAR T-cell therapy through an intravenous infusion following a preparatory lymphodepleting regimen using fludarabine and cyclophosphamide. The dose escalation design allows careful assessment of safety and biological effects. The study is planned to last up to approximately three years, with primary safety outcome monitoring over 2 years after treatment. During the study, participants will be closely monitored for adverse events, including treatment-emergent and serious side effects, as well as specific safety concerns related to cell therapy. Researchers will evaluate the therapys impact on disease activity and organ function through clinical assessments and laboratory tests. Participants will be followed for safety and efficacy outcomes until the study ends, expected in July 2028, with regular visits scheduled according to the study protocol.
CONDITIONS
Brief Title
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Aged 18 years to 75 years
- Adequate organ function including bone marrow, liver, coagulation, and pulmonary parameters as specified
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception; males with partners of childbearing potential must also use contraception
- Diagnosis of specific autoimmune diseases including anti-GBM disease, SLE/LN, AAV/AAGN, MN, SSc, IIM, or IgAN with disease-specific diagnostic and activity criteria met
- For each disease, meeting defined laboratory, clinical, or biopsy confirmation criteria as detailed in the protocol
- Stable standard therapy for IgAN patients with controlled blood pressure
You will not qualify if you...
- Severe active central nervous system lupus or drug-induced/secondary lupus in SLE/LN patients
- Drug-induced or secondary AAV/AAGN, or alveolar hemorrhage requiring ventilatory support
- Anuria over 7 days, long-term dialysis, moderate/severe pulmonary hemorrhage, or symptomatic heart failure in anti-GBM disease
- Secondary membranous nephropathy
- Severe rhabdomyolysis or extremely high CK levels in IIM
- Recent scleroderma renal crisis, cardiac tamponade, active digital ulcers, or digital gangrene in SSc
- Secondary IgA nephropathy or other kidney diseases that may confound assessment in IgAN patients
- Renal pathology showing extensive tubular atrophy, interstitial fibrosis, or glomerulosclerosis in IgAN
Research Team
P
Peng Yu
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