BridgeMD
New treatment option for Systemic Lupus Erythematosus
Official title An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
ClinicalTrials.gov ID: NCT06379646
What this study is testing
- What it's testing
- An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease
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
- Age ranges from 18 to 65 years old (including threshold), regardless of gender.
- Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.
- The functions of important organs meet the following requirements:
- Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×109/L; Hemoglobin ≥60g/L;
- Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;
You likely can't join if
- People with severe drug allergy or allergic constitution;
- the presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;
- people with central nervous system disorders (excluding pre-existing epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident...
- Patients with cardiac dysfunction;
- people with congenital immunoglobulin deficiency;
- History of malignant tumor in recent five years;
See the full eligibility criteria
Who can join
- Age ranges from 18 to 65 years old (including threshold), regardless of gender.
- Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.
- The functions of important organs meet the following requirements:
- Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×109/L; Hemoglobin ≥60g/L;
- Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;
- Renal function: creatinine clearance (CrCl) ≥30 ml/minute;
- Coagulation function: International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN;
- Heart function: good hemodynamic stability;
- Female people with fertility and male people whose partners are women of childbearing age are required to use medically approved contraception or abstinence during the study treatment period and at least 6 months after...
- Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up. Specific Recurrent refractory systemic lupus erythematosus
- Complies with the classification standards of the 2019 European Union Against Rheumatology/American Society of Rheumatology (EULAR/ACR) SLE;
- Disease activity score SELENA SLEDAI≥6 with at least one Injima Lupus Assessment Group Index (BILAG-2004) category A (severe presentation) or two Category B (moderate presentation) organ scores, or both; Or disease...
- Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and...
- Meet the 2002 AECG criteria for primary Sjogren's syndrome or the 2016 ACR/EULAR classification criteria;
- Disease activity ESSDAI≥6;
- Positive anti-SSA /Ro antibody;
- Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and...
- Meet the 2013 ACR classification criteria for systemic sclerosis;
- Positive antibodies related to systemic sclerosis;
- Diffuse sclerosis of the skin or active interstitial pneumonia (HRCT suggests ground glass exudation);
- Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and...
- Definition of progression: rapid skin progression (mRSS increase \>25%); Or progression of lung disease (a 10% reduction in FVC, or a more than 5% reduction in FVC with a 15% reduction in DLCO).
- Note: Articles 4 and 5 satisfy one or the other. Recurrent refractory/progressive inflammatory myopathy:
- Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (including DM, PM, ASS and NM);
- Positive myositis antibody;
- Patients with muscle involvement had an MMT-8 score of less than 142 and abnormal findings on at least two of the following five core measures (PhGA, PtGA, extra-muscular disease activity score ≥2; HAQ total score...
- Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and...
- Definition of progressive: myositis aggravation or rapid progression of interstitial pneumonia. Note: Clauses 4 and 5 satisfy one or the other. Recurrent/refractory ANCA-associated vasculitis:
- Meet the 2022ACR/EULAR diagnostic criteria for ANCA vasculitis, including microscopic polyvasculitis, granulomatous polyvasculitis, and eosinophilic granulomatous polyvasculitis.
- Anca-associated antibody positive (MPO-ANCA or PR3-ANCA positive);
- Birmingham vasculitis activity score (BVAS) ≥15 points (total 63 points), indicating vasculitis disease activity;
- Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and...
- Meet the diagnostic criteria for primary antiphospholipid syndrome as revised in Sydney 2006;
- Positive titers of phospholipid antibodies (IgG/IgM of LA, B2GP1 or acL, more than two positive tests within 12 weeks);
- Definition of relapse resistance: standard therapy with warfarin anticoagulant or replacement vitamin K antagonists (i.e., maintenance of the INR required for treatment) or with standard therapeutic dose of low...
- Catastrophic antiphospholipid syndrome needs to meet the following four criteria: (1) involvement of three or more organs, systems and/or tissues; (2) Symptoms appear within 1 week; (3) Histologically confirmed...
What rules you out
- People with severe drug allergy or allergic constitution;
- the presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;
- people with central nervous system disorders (excluding pre-existing epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis as a result of the...
- Patients with cardiac dysfunction;
- people with congenital immunoglobulin deficiency;
- History of malignant tumor in recent five years;
- people with end-stage renal failure;
- people with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer higher than the upper limit of detection; Hepatitis C virus (HCV) antibody positive and...
- Mental illness and severe cognitive impairment;
- Participants who had participated in other clinical trials within 3 months before enrollment;
- The duration of use of immunosuppressants that have therapeutic effects on the disease before enrollment was within five half-lives or biologics within four weeks;
- A woman who is pregnant or planning to become pregnant;
- The investigators believe that there are also people who could not be included in the study for other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.