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the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases

Clinical Study on the Safety and Efficacy of Targeted BCMA In Vivo LV Injection in the Treatment of Recurrent or Refractory Autoimmune Diseases

NCT07339540•Tongji Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. The age at the time of signing the informed consent form is ≥18 years old and ≤65 years old;
•2\. For cohort 1: recurrent or refractory systemic lupus erythematosus (all of the following four items must be met simultaneously)
•1. Diagnosed with SLE according to the 2012 SLICC or 2019 EULAR/ACR revised criteria.
•2. During screening, the patient exhibits positive anti-nuclear antibodies, and/or positive anti-ds-DNA antibodies, and/or positive anti-Smith antibodies.
•3. Before screening, patients must have received treatment with glucocorticoids combined with immunosuppressants and/or biologics for at least 3 months, with a stable dose for more than 2 weeks, and the disease remains active or the patient is intolerant to the medication.
•4. During the screening period, the SLEDAI-2K score is ≥8 points
•3\. For cohort 2: recurrent or refractory IgG4-related disease (all three of the following criteria must be met simultaneously)
•1. Meet the American College of Rheumatology (ACR)/EULAR 2019 classification criteria for IgG4-RD.
•2. Patients with clinical manifestations of recurrent or refractory IgG4-RD and ineffective conventional treatment
•3. Meet the clinical phenotype of "Mikulicz-system involvement"
+18 more criteria

Exclusion Criteria

•1\. For cohort 1: relapsed or refractory systemic lupus erythematosus
•1. Subjects with uncontrolled lupus crisis within 8 weeks before screening were assessed by the investigator as unsuitable for participation in this study.
•2. Before screening, patients with clinically significant central nervous system diseases or pathological changes not caused by lupus, including but not limited to cerebrovascular accident, aneurysm, epilepsy, convulsion/convulsion, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, brain organic syndrome, or mental illness, should be excluded.
•2\. For cohort 3: relapsed or refractory systemic sclerosis. High-risk pulmonary arterial hypertension, according to the "Risk Stratification of Arterial Pulmonary Arterial Hypertension (PAH)" in the "Guidelines for the Diagnosis and Treatment of Pulmonary Arterial Hypertension in China (2021 Edition)".
•3\. History of major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
•4\. Subjects with a history of ≥ Grade 2 bleeding within 30 days prior to screening, as assessed by the investigator, were deemed unsuitable for enrollment.
•5\. Use of any live vaccines against infectious diseases within 8 weeks before infusion.
•6\. Received any treatment using vesicular stomatitis virus G (VSVG) pseudotype virus.
•7\. The subject has a history or evidence of suicidal thoughts within 6 months before signing the ICF, or any suicidal behavior within 12 months before signing the ICF, and the researcher believes that there is a significant risk of suicide.
•8\. Pregnant or lactating women;
+13 more criteria

Locations (1)

Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Key Dates

Start Date

November 4, 2025

Primary Completion Date

October 30, 2028

Completion Date

October 30, 2028

Last Updated

January 14, 2026

Enrollment

ESTIMATED participants

Conditions

Recurrent or Refractory Systemic Lupus ErythematosusRecurrent or Refractory IgG4 Related DiseasesRecurrent or Refractory Systemic SclerosisRecurrent or Refractory Idiopathic Inflammatory MyopathyRecurrent or Refractory ANCA Associated Vasculitis

Interventions

V001-BCMA

DRUG

Contacts

lingli Dong, professor

CONTACT

83665519 tjhdongll@163.com