Actively Recruiting
Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases
Led by Nanjing Bioheng Biotech Co., Ltd. · Updated on 2026-02-02
18
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new targeted CAR-T cell therapy called RD06-05 for adults with active autoimmune diseases including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), neuromyelitis optica spectrum disorder (NMOSD), multiple sclerosis (MS), and myasthenia gravis (MG). This early-phase clinical trial aims to evaluate the safety, tolerability, how the body processes the therapy, and its effects in these patients. The study is sponsored by Nanjing Bioheng Biotech Co., Ltd. Participants will receive RD06-05 CAR-T cell injections given intravenously after a preparatory lymphodepleting treatment with fludarabine and cyclophosphamide. The study includes careful monitoring over a two-year period to observe adverse events and other outcomes related to the treatment. The trial does not use placebo or masking, and all participants receive the experimental therapy. During the study, patients will undergo regular assessments including laboratory tests for liver, kidney, blood, and coagulation function, oxygen saturation, and heart function via echocardiography. Women of childbearing potential will have pregnancy tests and must use effective contraception. Researchers will track treatment safety by recording adverse events and will evaluate clinical disease activity using established criteria specific to each autoimmune condition. Participant involvement may last at least two years to monitor long-term effects and safety.
CONDITIONS
Brief Title
Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Aged 18 to 70 years, any gender
- Liver function: ALT and AST less than 3 times upper limit of normal, total bilirubin less than 2 times upper limit (except Gilbert's syndrome)
- Kidney function: creatinine less than 1.5 times upper limit or creatinine clearance at least 40 ml/min
- Blood counts: neutrophils at least 1x10^9/L, hemoglobin at least 60 g/L, platelets at least 20x10^9/L, lymphocytes above 0.3x10^9/L
- Coagulation: INR or prothrombin time less than or equal to 1.5 times upper limit
- Oxygen saturation at rest at least 92% in room air
- Left ventricular ejection fraction at least 50%
- Negative pregnancy test for women of childbearing potential
- Use of effective contraception for women and men of childbearing potential during and after treatment as specified
- Confirmed diagnosis of autoimmune diseases according to established criteria for SLE, systemic sclerosis, ANCA-associated vasculitis, idiopathic inflammatory myopathies, or Sjögren's syndrome with active disease as defined
You will not qualify if you...
- Uncontrolled lupus crisis within 8 weeks before screening for SLE patients
- Severe rhabdomyolysis or creatine kinase levels 120 times upper limit at screening for IIM patients
- Severe asthma or COPD are excluded; mild or moderate stable asthma or COPD allowed
- Active infection requiring systemic treatment within 2 weeks before the study
- Positive for hepatitis B surface antigen or hepatitis B core antibody with detectable virus, hepatitis C antibody with detectable virus, HIV antibody, or syphilis antibody
- Pregnant or breastfeeding women
- Any condition that may risk patient safety or interfere with study participation or result interpretation as judged by investigator
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.
Duration - A few days before treatment
Participants receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to CAR T-cell infusion.
Duration - Single administration with monitoring during treatment phase
Participants receive targeted CD19/BCMA CAR T-cell therapy intravenously following lymphodepleting therapy.
1 treatment visit (in-person) with frequent monitoring
Duration - Up to 2 years
Participants are monitored for adverse events and overall safety for up to 2 years after treatment.
Regular visits over 2 years for safety assessments
Trial Site Locations
Total: 1 location
1
The First People's Hospital of Lianyungang
Lianyungang, Jiangus, China, 222000
Actively Recruiting
Research Team
X
Xiao Shi
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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