Actively Recruiting
A Clinical Study of the Safety, Efficacy, and Cell Pharmacokinetics of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases
Led by Nanjing Bioheng Biotech Co., Ltd. · Updated on 2025-10-02
84
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and effectiveness of a new CAR-T cell therapy called RD06-05. This therapy targets CD19 and BCMA markers and is being studied for several autoimmune diseases, including systemic lupus erythematosus (SLE) with lupus nephritis (LN), ANCA-associated vasculitis and glomerulonephritis, anti-glomerular basement membrane (GBM) disease, membranous nephropathy (MN), systemic sclerosis (SSc), and idiopathic inflammatory myopathy (IIM). The study is an early phase 1, exploratory, single-arm, open-label dose-escalation trial led by Nanjing Bioheng Biotech Co., Ltd. Participants will receive RD06-05 CAR-T cell therapy intravenously after a preparatory treatment with fludarabine and cyclophosphamide to reduce lymphocytes. The trial involves dose escalation to assess safety and tolerability with a focus on adverse events during treatment. The study treatment is given once, and patients will be monitored for two years to observe effects and side effects. During the study, participants will be closely monitored for adverse events, serious adverse events, and specific safety concerns related to the therapy. Researchers will assess blood tests, organ functions, and disease activity scores relevant to each autoimmune disease. Women of childbearing potential and their partners must use effective contraception during the study and for six months afterward. The total participation time includes the treatment and a two-year follow-up period to evaluate safety and treatment impact.
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 and older up to 75 years.
- Adequate organ function including bone marrow, liver, coagulation, and lung function as defined by specific laboratory and clinical criteria.
- Female subjects of childbearing potential must have a negative pregnancy test.
- Use of highly effective contraception from consent until 6 months after treatment for females of childbearing potential and males with partners of childbearing potential.
- Diagnosis of specific autoimmune diseases including anti-GBM disease with antibody positivity and renal involvement; SLE/LN with diagnostic antibody positivity and disease activity; AAV/AAGN with classification criteria and antibody positivity; primary membranous nephropathy with biopsy confirmation and high-risk or relapsed/refractory status; systemic sclerosis with diffuse cutaneous involvement; idiopathic inflammatory myopathy with classification criteria and subtypes.
You will not qualify if you...
- Severe active central nervous system lupus or neuropsychiatric symptoms for SLE/LN patients.
- Drug-induced or secondary lupus for SLE/LN patients.
- Drug-induced or secondary AAV/AAGN.
- Alveolar hemorrhage requiring invasive ventilatory support for AAV/AAGN patients.
- Anuria for more than 7 days for anti-GBM disease patients.
- Dialysis dependence for more than 30 days for anti-GBM disease patients.
- Moderate or severe pulmonary hemorrhage requiring ventilation, oxygen, or transfusion for anti-GBM disease patients.
- Symptomatic congestive heart failure requiring medication or significant peripheral edema for anti-GBM disease patients.
- Secondary membranous nephropathy.
- Severe rhabdomyolysis or very high creatine kinase levels for IIM patients.
- Recent scleroderma renal crisis or cardiac tamponade for SSc patients.
- Recent active infection or digital gangrene for SSc patients.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - A few days prior to treatment
Participants receive lymphodepleting therapy consisting of fludarabine and cyclophosphamide before the CAR T-cell infusion.
1 to 2 visits (in-person)
Duration - Single treatment day with monitoring
Participants receive a single intravenous infusion of RD06-05 CAR T-cell therapy following the lymphodepleting regimen.
1 treatment visit (in-person)
Duration - Up to 2 years
Participants are monitored for safety, efficacy, and cell pharmacokinetics for up to 2 years after treatment.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Bioheng Study site
Shanghai, China
Actively Recruiting
Research Team
P
Peng Yu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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