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Tests treatment safety and results for Recurrent or Refractory Systemic Lupus Erythematosus
Official title the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07339540
What this study is testing
What is V001-BCMA?
V001-BCMA is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for recurrent or refractory systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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)
- Diagnosed with SLE according to the 2012 SLICC or 2019 EULAR/ACR revised criteria.
- During screening, the patient exhibits positive anti-nuclear antibodies, and/or positive anti-ds-DNA antibodies, and/or positive anti-Smith...
- Before screening, patients must have received treatment with glucocorticoids combined with immunosuppressants and/or biologics for at least 3 months...
You likely can't join if
- 1\. For cohort 1: relapsed or refractory systemic lupus erythematosus
- people with uncontrolled lupus crisis within 8 weeks before screening were assessed by the investigator as unsuitable for participation in this study.
- Before screening, patients with clinically significant central nervous system diseases or pathological changes not caused by lupus, including but not...
- 2\. For cohort 3: relapsed or refractory systemic sclerosis. High-risk pulmonary arterial hypertension, according to the "Risk Stratification of...
- 3\. History of major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- 4\. people with a history of ≥ Grade 2 bleeding within 30 days prior to screening, as assessed by the investigator, were deemed unsuitable for...
See the full eligibility criteria
Who can join
- 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)
- Diagnosed with SLE according to the 2012 SLICC or 2019 EULAR/ACR revised criteria.
- During screening, the patient exhibits positive anti-nuclear antibodies, and/or positive anti-ds-DNA antibodies, and/or positive anti-Smith antibodies.
- 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...
- 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)
- Meet the American College of Rheumatology (ACR)/EULAR 2019 classification criteria for IgG4-RD.
- Patients with clinical manifestations of recurrent or refractory IgG4-RD and ineffective conventional treatment
- Meet the clinical phenotype of "Mikulicz-system involvement"
- 4\. For cohort 3: relapsed or refractory systemic sclerosis (all of the following 5 items must be met simultaneously)
- Meet the 2013 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) classification criteria for SSc.
- Anti-Scl 70 antibody positive, or anti-centromere protein antibody positive, or anti-RNA polymerase III antibody positive
- Patients with a modified Rodnan skin score (mRSS) of ≥10 at screening
- 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...
- 5\. For cohort 4: relapsed or refractory idiopathic inflammatory myopathies (all of the following 5 criteria must be met)
- Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathies (including dermatomyositis DM, polymyositis PM, anti-synthetase syndrome ASS, and necrotizing myositis NM).
- At least one myositis-specific antibody (MSA) or myositis-associated antibody (MAA) positive (+ or above)
- During the screening period, the patient meets 2 of the following criteria: PGA(VAS)≥2cm (VAS-10cm scale); PtGA(VAS)≥2cm (VAS-10cm scale); HAQ\>0.25; one or more muscle enzymes are elevated (CK, LDH, AST, ALT) ≥1.5×ULN...
- After at least 3 months of treatment with glucocorticoids and immunosuppressants and/or biologics, with stable doses for more than 2 weeks, the disease remains active or the patient is intolerant to the medication.
- Active myositis is present in muscle biopsy or muscle MRI during the screening period or within the first 6 months before the screening period.
- 6\. For cohort 5: relapsed or refractory AAV (all three of the following conditions must be met simultaneously)
- According to the 2022 ACR/EULAR criteria, the patient is diagnosed with AAV (GPA or MPA subtype). According to the KDIGO guidelines, after 3 months of treatment with glucocorticoids combined with immunosuppressants such...
- The patient is currently or has been in the course of AAV related antibodies positive;
- Severe disease requiring treatment (BVAS score ≥3.0).
- 7\. Possess sufficient organ function
- 8\. Men with fertility and women of childbearing age must agree to use effective contraception from the time they sign the informed consent form until 1 year after the study drug is administered. Blood pregnancy tests...
- 9\. The subject or his/her guardian agrees to participate in this clinical study and signs the informed consent form (ICF), indicating that he/she understands the purpose and procedures of this clinical study and is...
What rules you out
- 1\. For cohort 1: relapsed or refractory systemic lupus erythematosus
- people with uncontrolled lupus crisis within 8 weeks before screening were assessed by the investigator as unsuitable for participation in this study.
- 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...
- 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...
- 3\. History of major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- 4\. people 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...
- 8\. Pregnant or lactating women;
- 9\. The patient has a history of severe and/or uncontrolled liver, gastrointestinal, kidney, lung, cardiovascular, psychiatric, neurological, or musculoskeletal diseases, hypertension, or any other medical condition...
- 10\. Suffered from malignant tumor within 3 years before screening, except for the following conditions: received radical treatment for malignant tumor and had no known active disease within ≥3 years before enrollment...
- 11\. Received any B-cell depleting biologic therapy (e.g., rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab, etc.) within 3 months prior to infusion, unless B-cell recovery is proven.
- 12\. Received immunosuppressants and other small molecule drugs within 3 days before infusion.
- 13\. Use of any other clinical research drugs within 4 weeks before infusion. However, if the study treatment is ineffective or the disease progresses during the study period, and at least 3 half-lives have elapsed...
- 14\. The patient has received live vaccines or live therapeutic infectious pathogens within 2 weeks before infusion.
- 15\. The presence of chronic and active hepatitis B (excluding HBV-DNA levels below 500IU/ml), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, or syphilis infection;
- 16\. Active infection exists, requiring intravenous antibiotic therapy or hospitalization;
- 17\. Patients who have undergone major surgery other than diagnosis or biopsy within 4 weeks before infusion, or are expected to undergo major surgery during the study period; note: patients who plan to undergo surgical...
- 18\. Obvious evidence of cardiovascular disease as follows: a. N-terminal pro-B-type natriuretic peptide (NT-proBNP) \> 8500ng/L; b. New York Heart Association (NYHA) classification of heart failure as III or IV; c...
- 19\. Individuals who have known allergies, hypersensitivity reactions, intolerances, or contraindications to any component of V001-BCMA, or who have previously experienced severe allergic reactions.
- 20\. Those who were deemed unsuitable for infusion or otherwise unsuitable for participation in the study by the researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.