Actively Recruiting
the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases
Led by Tongji Hospital · Updated on 2026-01-14
45
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed as a single arm, open label, single center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetic or pharmacodynamic characteristics of the investigational drug V001-BCMA in autoimmune disease.
CONDITIONS
Official Title
the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old at the time of signing the consent form
- For systemic lupus erythematosus (SLE) cohort: diagnosed by 2012 SLICC or 2019 EULAR/ACR criteria; positive for specific antibodies during screening; treated with glucocorticoids plus immunosuppressants or biologics for at least 3 months with stable dose over 2 weeks; active disease with SLEDAI-2K score of 8 or higher
- For IgG4-related disease cohort: meet 2019 ACR/EULAR criteria; have recurrent or refractory disease with ineffective conventional treatment; show "Mikulicz-system involvement"
- For systemic sclerosis cohort: meet 2013 ACR/EULAR criteria; positive for specific antibodies; modified Rodnan skin score of 10 or higher; treated with glucocorticoids plus immunosuppressants or biologics for at least 3 months with stable dose over 2 weeks; active or intolerant disease
- For idiopathic inflammatory myopathies cohort: meet 2017 EULAR/ACR criteria; positive for at least one myositis-specific or associated antibody; meet at least two clinical or laboratory criteria during screening; treated with glucocorticoids plus immunosuppressants or biologics for at least 3 months with stable dose over 2 weeks; active myositis shown by biopsy or MRI within 6 months
- For ANCA-associated vasculitis cohort: diagnosed by 2022 ACR/EULAR criteria; treated with glucocorticoids plus immunosuppressants or biologics with stable dose over 2 weeks; positive for related antibodies; active severe disease with BVAS score of 3 or higher
- Have sufficient organ function
- Agree to use effective contraception from signing consent until 1 year after study drug administration if of childbearing potential
- Agree to participate and sign informed consent
You will not qualify if you...
- For SLE cohort: uncontrolled lupus crisis within 8 weeks before screening; clinically significant central nervous system diseases unrelated to lupus
- For systemic sclerosis cohort: high-risk pulmonary arterial hypertension
- History of major organ or bone marrow transplantation
- History of grade 2 or higher bleeding within 30 days before screening
- Use of live vaccines within 8 weeks before infusion
- Previous treatment using vesicular stomatitis virus G pseudotype virus
- History or evidence of suicidal thoughts or behavior within 6 to 12 months before consent
- Pregnant or lactating women
- Severe or uncontrolled diseases affecting liver, gastrointestinal, kidney, lung, heart, psychiatric, neurological, or musculoskeletal systems; hypertension; or other conditions affecting safety or study integrity
- Malignant tumor within 3 years before screening except fully treated non-melanoma skin cancer or tumors with no active disease for 3 years
- Use of B-cell depleting biologic therapy within 3 months before infusion unless B-cell recovery proven
- Use of immunosuppressants or small molecule drugs within 3 days before infusion
- Use of other clinical research drugs within 4 weeks before infusion unless prior treatment ineffective or disease progressed and at least 3 half-lives elapsed
- Use of live vaccines or live therapeutic infectious agents within 2 weeks before infusion
- Chronic and active infections including hepatitis B, hepatitis C, HIV, or syphilis
- Active infection requiring intravenous antibiotics or hospitalization
- Major surgery within 4 weeks before infusion or expected during study except minor local anesthesia procedures
- Significant cardiovascular disease including high NT-proBNP, advanced heart failure, recent unstable angina or myocardial infarction, recent coronary interventions
- Known allergies or severe reactions to any component of V001-BCMA
- Deemed unsuitable for infusion or study participation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
L
lingli Dong, professor
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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