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
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG
CONDITIONS
Official Title
Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily agree to the study and sign the informed consent form.
- Age between 18 and 70 years, all genders.
- Liver function with ALT and AST not exceeding 3 times the upper limit of normal, and total bilirubin not exceeding 2 times the upper limit (except Gilbert's syndrome).
- Kidney function with creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 40 ml/min.
- Blood counts with neutrophils at least 1 x 10^9/L, hemoglobin at least 60 g/L, platelets at least 20 x 10^9/L, and lymphocytes above 0.3 x 10^9/L.
- Coagulation tests with INR or prothrombin time no greater than 1.5 times upper limit of normal.
- Oxygen saturation at rest in room air at least 92%.
- Left ventricular ejection fraction of 50% or higher on echocardiography.
- Negative pregnancy test in women of childbearing potential at screening.
- Women of childbearing potential must use effective contraception for at least 28 days before and up to 12 months after treatment; men must use barrier contraception and avoid sperm donation during the trial.
- Confirmed diagnosis of SLE with positive antibodies and SLEDAI-2K score above 6 and clinical score above 4.
- Confirmed diagnosis of diffuse cutaneous systemic sclerosis with disease duration of 6 years or less.
- Diagnosis of ANCA-associated vasculitis with positive MPO-ANCA or PR3-ANCA antibodies.
- Diagnosis of idiopathic inflammatory myopathies with active disease meeting specified clinical and laboratory criteria.
- Diagnosis of primary Sjögren's Syndrome with positive anti-SSA/Ro antibodies and ESSDAI score of 5 or higher.
You will not qualify if you...
- SLE patients with uncontrolled severe disease complications within 8 weeks before screening.
- IIM patients with severe rhabdomyolysis or creatine kinase levels above 120 times the upper limit of normal.
- Patients with active infection requiring systemic treatment within 2 weeks before study procedures.
- Positive for hepatitis B surface antigen or active hepatitis B infection, hepatitis C infection, HIV, or syphilis.
- Pregnant or breastfeeding women.
- Any condition that poses a safety risk, affects participation, or confounds study results as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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