Actively Recruiting
CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases
Led by Tongji Hospital · Updated on 2026-05-12
36
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
N
Nanjing Bioheng Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This single-arm, open-label investigator-initiated trial (IIT) evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with autoimmune neurological diseases, including Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE), and other B-cell-mediated neuroautoimmune disorders. In this study, the dose of CAR-T cells administered is 10×10⁶ CAR⁺T cells per kilogram of body weight. Investigators may decide whether to add other dose groups based on the subjects' safety data, pharmacokinetic (PK) data, pharmacodynamic (PD) data, and preliminary efficacy data. For each indication, 6 to 9 subjects will be enrolled, with a total of 24 to 36 subjects planned for enrollment in the entire study.
CONDITIONS
Official Title
CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate and sign informed consent.
- Aged 18 to 70 years, any gender.
- Liver function: ALT and AST �3 3 times ULN; total bilirubin �3 2 times ULN (except Gilbert's syndrome).
- Renal function: serum creatinine �3 1.5 times ULN or creatinine clearance �3 40 ml/min.
- Blood counts: neutrophils �5 1 �d7 10�9/L; hemoglobin �5 60 g/L; platelets �5 20 �d7 10�9/L; lymphocytes �3 0.3 �d7 10�9/L.
- Coagulation: INR or PT �3 1.5 times ULN.
- Oxygen saturation �5 92% at rest on room air.
- Echocardiography: LVEF �5 50%.
- Female patients of childbearing potential must have negative pregnancy test.
- Females of childbearing potential must use effective contraception from 28 days before apheresis until 12 months after infusion; males must use barrier contraception and avoid semen donation during the same period.
- Specific criteria for MS, MG, CIDP, and AE patients including diagnosis confirmation, disease activity scores, prior treatments, and stable treatment regimens as detailed in the protocol.
You will not qualify if you...
- Primary diagnosis of autoimmune disease other than the study disease that may confound results.
- Other significant CNS diseases or brain damage prior to screening.
- History of bone marrow, stem cell, or solid organ transplantation.
- For MG patients, uncontrolled myasthenic crisis within 2 weeks before screening.
- For CIDP patients, pure sensory CIDP.
- Significant cardiovascular dysfunction within 12 months before screening.
- Significant lung or heart conditions making participation unsafe.
- Severe asthma or COPD; mild/moderate asthma or COPD with stable treatment allowed.
- History of malignancy within 5 years except treated non-melanoma skin cancer or carcinoma in situ.
- Pregnant or lactating women.
- History of recurrent serious infections requiring hospitalization.
- Active infection requiring systemic treatment within 2 weeks before lymphodepletion.
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis.
- Recent live-attenuated vaccination or planned vaccination with such vaccines during the study.
- Recent high-dose corticosteroids or inability to taper before lymphodepletion.
- Inability to taper or discontinue background treatment as required.
- Recent plasma exchange, immunoadsorption, or IVIG treatment.
- Allergy or intolerance to calcineurin inhibitors.
- Recent or expected need for renal replacement therapy.
- History of drug or alcohol abuse within 1 year.
- History or risk of suicide as assessed by investigator.
- Use of other investigational drugs recently.
- Hypersensitivity to study drug components.
- Any other condition that may affect study participation or safety as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
K
Ke Shang
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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