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New treatment option for REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS
Official title IASO207 Injection for Active Refractory Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT07617740
What this study is testing
What is IASO207 Injection?
IASO207 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for 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 is a single-center, open-label, exploratory clinical study designed to evaluate the efficacy and safety of IASO207 Injection (in vivo CAR-T) in patients with active refractory systemic lupus erythematosus.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 75
You may be able to join if
- people aged 18-75 years old, regardless of gender.
- people diagnosed with active refractory SLE: a) Confirmed by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology...
- Positive for disease-related pathogenic antibodies: Anti-nuclear antibody (ANA) positive and/or anti-dsDNA positive and/or anti-Smith positive.
- Allowed to use ≤ 20mg/d prednisone or equivalent dose of corticosteroids at screening, and use at a stable dose for at least 2 weeks. Note: Local or...
- If antimalarial treatment has been initiated for ≥ 12 weeks before screening and is used at a stable dose for at least 8 weeks, it is allowed to...
You likely can't join if
- Disease-related:
- Diagnosed with drug-induced SLE.
- Complicated with other autoimmune diseases that may affect the assessment of the study, including but not limited to Sjögren's syndrome, psoriasis...
- Had a catastrophic antiphospholipid syndrome or developed a severe antiphospholipid syndrome within 1 year before screening.
- The study disease involved neurological symptoms with a BILAG-2004 activity score of class A. Other medical history-related:
- Known primary immunodeficiency (congenital or acquired).
See the full eligibility criteria
Who can join
- people aged 18-75 years old, regardless of gender.
- people diagnosed with active refractory SLE: a) Confirmed by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus...
- Positive for disease-related pathogenic antibodies: Anti-nuclear antibody (ANA) positive and/or anti-dsDNA positive and/or anti-Smith positive.
- Allowed to use ≤ 20mg/d prednisone or equivalent dose of corticosteroids at screening, and use at a stable dose for at least 2 weeks. Note: Local or inhaled corticosteroids (or its immunomodulators) can be used...
- If antimalarial treatment has been initiated for ≥ 12 weeks before screening and is used at a stable dose for at least 8 weeks, it is allowed to continue in the study (maximum hydroxychloroquine dose ≤ 400mg/d).
- If immunosuppressants have been used before screening, they must be used at a stable dose for at least 4 weeks.
- Laboratory tests must meet the following conditions: a) Blood routine: Absolute neutrophil count (ANC) ≥ 1.0×10\^9/L; Absolute lymphocyte count (ALC) ≥ 0.3×10\^9/L; Hemoglobin ≥ 60 g/L; Platelets ≥ 50×10\^9/L b) Liver...
- The subject and their spouse agree to take effective contraceptive measures (excluding safe period contraception) from the time of signing the informed consent form by the subject until one year after IASO207 injection...
- The subject must agree to sign or personally write and present the signed informed consent form approved by the ethics committee before starting any screening procedure.
What rules you out
- Disease-related:
- Diagnosed with drug-induced SLE.
- Complicated with other autoimmune diseases that may affect the assessment of the study, including but not limited to Sjögren's syndrome, psoriasis, rheumatoid arthritis.
- Had a catastrophic antiphospholipid syndrome or developed a severe antiphospholipid syndrome within 1 year before screening.
- The study disease involved neurological symptoms with a BILAG-2004 activity score of class A. Other medical history-related:
- Known primary immunodeficiency (congenital or acquired).
- The subject has uncontrollable active fungal, viral, bacterial or other infections (existing persistent infection-related signs/symptoms, not improved after appropriate anti-infection treatment) or requires intravenous...
- Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and abnormal peripheral blood hepatitis B virus (HBV) DNA detection (defined as HBV DNA quantification above the normal...
- Severe heart disease: including but not limited to unstable angina pectoris and/or myocardial infarction within 12 months of screening, any congestive heart failure (NYHA classification ≥ III), and a history of severe...
- Severe asthma or chronic obstructive pulmonary disease (COPD), with stable treatment considered for mild or moderate asthma or COPD by the investigator and sponsor; or resting arterial blood oxygen saturation \< 91%.
- Evaluated by the investigator as having a severe bleeding risk.
- Evaluated by the investigator as having severe liver dysfunction.
- History of severe kidney disease; or eGFR \< 30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- Acute cerebrovascular disease events occurred within 6 months before enrollment, including transient ischemic attack or stroke history.
- Any severe and/or uncontrolled comorbid diseases as assessed by the investigator.
- Had a malignant tumor within 5 years before screening, excluding cured cervical carcinoma in situ, basal cell or squamous cell skin cancer, locally advanced prostate cancer after radical surgery, breast duct carcinoma...
- Had a clear history of mental disorder or a history of substance abuse for mental disorders that cannot be quit.
- Known allergy to the components of IASO207 injection or to the supportive drugs required for the toxicity management of CAR-T cell therapy (such as tocilizumab). Previous and concurrent treatments:
- History of organ transplantation.
- History of autologous or allogeneic stem cell transplantation.
- History of cell therapy or CD19-targeted drug treatment.
- Received targeted CD20 biologic therapy within 12 weeks before screening, such as rituximab, obinutuzumab.
- Received plasma exchange or immunoadsorption treatment within 12 weeks before screening.
- Had or planned to have major surgery or surgical treatment caused by any reason within 12 weeks before screening.
- Have participated in the treatment of other investigational drugs (except for placebo) within the previous 4 weeks or 5 half-lives (whichever is longer);
- Have received a BAFF antagonist, such as belimumab or tixagevimab, within the previous 4 weeks;
- Have received live attenuated vaccine within the previous 4 weeks;
- Pregnant or lactating women;
- Other situations deemed unsuitable for inclusion by the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.