Actively Recruiting
Clinical Study on the Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Neurological Autoimmune Diseases
Led by Tongji Hospital · Updated on 2026-05-12
36
Participants Needed
1
Research Sites
100 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
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and effectiveness of RD06-05, a universal CAR-T cell therapy targeting CD19/BCMA, in patients with autoimmune neurological diseases. These conditions include Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE), and other B-cell-mediated neuroautoimmune disorders. This early phase 1, open-label, single-arm trial plans to enroll 24 to 36 participants, with 6 to 9 subjects per disease group. Participants undergo lymphodepleting chemotherapy with fludarabine and cyclophosphamide for three days before receiving a single intravenous infusion of RD06-05 CAR-T cells dosed at 1 x 10^7 CAR-positive T cells per kilogram of body weight. The investigators may adjust dosing or add groups based on safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy data. The study includes only one treatment group receiving this CAR-T cell therapy following conditioning chemotherapy. During the study, participants will be monitored from the day of infusion up to 24 months to assess safety by tracking adverse events, including serious and special interest events. Researchers will measure disease-specific outcomes such as relapse rates and MRI changes in MS, symptom scores in MG, disability scales in CIDP, and cognitive and functional assessments in AE. Blood samples will be collected at multiple time points to study the therapy's behavior in the body. The total participation duration spans up to two years after infusion, during which safety and effectiveness data will be gathered.
CONDITIONS
Brief 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.
- Adequate organ function and laboratory results within defined limits.
- Normal oxygen saturation (SpO2 ≥ 92%) and heart function (LVEF ≥ 50%).
- Negative pregnancy test for females of childbearing potential; use effective contraception.
- Diagnosed with Relapsing or Progressive Multiple Sclerosis meeting specific diagnostic criteria and MRI findings.
- Diagnosed with generalized Myasthenia Gravis meeting clinical and antibody criteria.
- Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy meeting clinical and diagnostic criteria.
- Diagnosed with Autoimmune Encephalitis according to 2016 criteria with recent attack and disability scores.
- Stable or active disease requiring treatment as defined per condition.
You will not qualify if you...
- Diagnosis of autoimmune diseases other than the study disease that may affect evaluation.
- Other significant CNS diseases such as stroke, epilepsy, dementia, or psychosis.
- History or planned organ or bone marrow transplantation.
- Uncontrolled myasthenic crisis within 2 weeks (for MG patients).
- Pure sensory CIDP (for CIDP patients).
- Significant cardiovascular or pulmonary dysfunction within past year.
- Severe asthma or COPD; mild/moderate cases allowed if stable.
- History of malignancy within 5 years except certain treated cancers.
- Pregnant or breastfeeding females.
- Recurrent serious infections or active infections requiring treatment.
- Positive tests for hepatitis B, C, HIV, or syphilis.
- Live vaccine within 4 weeks before chemotherapy or planned during study.
- Recent high-dose corticosteroids or inability to taper medications as required.
- Recent plasma exchange, immunoadsorption, or IVIG treatment.
- Allergy to study drug components or chemotherapy.
- Recent renal replacement therapy or expected need during study.
- History of drug or alcohol abuse within 1 year.
- Significant suicide risk or ideation within past year.
- Use of other investigational drugs recently.
- Any other condition that may affect safety or study results.
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 - 6 days (from Day -5 to Day 0)
Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide for 3 days, followed by a single intravenous infusion of CD19/BCMA-targeted CAR-T cells.
Daily visits for 6 consecutive days
Duration - Up to 24 months
Participants are monitored for safety, efficacy, and pharmacokinetics up to 24 months after the CAR-T cell infusion.
Visits on Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
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
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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