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New treatment option for Systemic Lupus Erythematosus
Official title BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT06794008
What this study is testing
What is BCMA-CD19 CAR-T therapy?
BCMA-CD19 CAR-T therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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
- The objective of this study is to evaluate the efficacy and safety of BCMA/CD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.
- Phase 2: a mid-size study of how well it works
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, 18-65 years old (inclusive), weight \>=45kg, male and female;
- The diagnosis of each disease meets the following criteria: Systemic lupus erythematosus: 1997 ACR classification criteria or 2012 SLICC...
- Patients with Behcet's disease must be active patients who meet the following conditions, and the active phase is defined as the emergence of new...
- Patients with active inflammatory myopathy need to meet the following additional conditions: Active myositis as defined by the Baseline Freehand...
- ANCA-associated vasculitis: A. Comply with GPA/MPA/EGPA classification standards; B. Patients with severe vasculitis activity (meeting at least one...
You likely can't join if
- Use of rituximab or other monoclonal antibodies within 1.6 months.
- Received high-dose glucocorticoids (\>1 mg/kg/d) within 1 month.
- Serious complications: including heart failure (\>= NYHA Class III), renal insufficiency (creatinine clearance \<=30 ml/min), hepatic insufficiency...
- Other severe, progressive, or uncontrollable hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral diseases...
- Known allergies, hyperreactivity, or intolerance to IL-2 or its excipients.
- Have a serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection)...
See the full eligibility criteria
- Age, 18-65 years old (inclusive), weight \>=45kg, male and female;
- The diagnosis of each disease meets the following criteria: Systemic lupus erythematosus: 1997 ACR classification criteria or 2012 SLICC classification criteria Sjögren's syndrome: 2002 International Classification of...
- Patients with Behcet's disease must be active patients who meet the following conditions, and the active phase is defined as the emergence of new symptoms or the deterioration of existing symptoms, and one of the...
- Patients with active inflammatory myopathy need to meet the following additional conditions: Active myositis as defined by the Baseline Freehand Muscle Strength Test (MMT-8) of no more than 125/150 and at least 2...
- ANCA-associated vasculitis: A. Comply with GPA/MPA/EGPA classification standards; B. Patients with severe vasculitis activity (meeting at least one of the following conditions); a) Renal involvement is characterized by...
- Additional Enrollment Criteria for Systemic Sclerosis: people are at high risk of fatal outcomes based on the following prognostic factors: people must have the following "a" , and at least one of "b" or "c". a) Diffuse...
- Additional enrollment criteria for systemic lupus erythematosus A. The SLEDAI score of the patient before enrollment \>= 7 points B. Failure to receive the following treatments: oral prednisone \>=20 mg/d...
- Additional enrollment criteria for antiphospholipid syndrome A. Cardiolipin antibody, lupus anticoagulant factor, and anti-β2-glycoprotein 1 antibody were all positive before enrollment. B. History of thromboembolism or...
- Sjögren's disease additional enrollment criteria A. Positive anti-Ro/SSA antibody screen. B. ESSDAI\>= 6 POINTS
- Additional enrollment criteria for IgG4-related diseases (confirmed: A+ B+C) A. Clinical examination showing the presence of characteristic diffuse/local swelling or masses in a single or multiple organs. B. Blood tests...
- Use of rituximab or other monoclonal antibodies within 1.6 months.
- Received high-dose glucocorticoids (\>1 mg/kg/d) within 1 month.
- Serious complications: including heart failure (\>= NYHA Class III), renal insufficiency (creatinine clearance \<=30 ml/min), hepatic insufficiency (serum ALT or AST greater than three times the upper limit of normal...
- Other severe, progressive, or uncontrollable hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral diseases (including demyelinating diseases such as multiple sclerosis).
- Known allergies, hyperreactivity, or intolerance to IL-2 or its excipients.
- Have a serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), or hospitalization for infection, or use of intravenous antibiotics...
- Chest imaging showing malignancy or current activity within 3 months prior to the first use of study drug Abnormalities in sexually transmitted infections (including tuberculosis).
- Infection with HIV (HIV antibody-positive serology) or hepatitis C (Hep C antibody-positive serology). If seropositive, it is advisable to consult a physician with expertise in the treatment of HIV or hepatitis C virus...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 Beijing, Beijing 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.