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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
ClinicalTrials.gov ID: NCT06249438
What this study is testing
What is CD20/BCMA-directed CAR-T cells?
CD20/BCMA-directed CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus (sle).
Also referred to as C-CAR168.
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 an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy
- 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 70
You may be able to join if
- 18 to 70 years old at the time of signing the Informed Consent Form (ICF).
- Diagnosed as SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia...
- Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks...
- Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.
You likely can't join if
- Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA...
- Uncontrolled active infection.
- Live vaccine injection within 4 weeks prior to signing the ICF.
- Major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history.
- Severe cardiovascular diseases within the past 6 months prior to screening.
- ≥ Grade 2 bleeding within the past 30 days prior to screening, or requiring long-term anticoagulants treatment.
See the full eligibility criteria
- 18 to 70 years old at the time of signing the Informed Consent Form (ICF).
- Diagnosed as SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG)/Systemic Sclerosis (SSc) according to recognized diagnostic...
- Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated with at least two immunosuppressants...
- Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.
- Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.
- Uncontrolled active infection.
- Live vaccine injection within 4 weeks prior to signing the ICF.
- Major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history.
- Severe cardiovascular diseases within the past 6 months prior to screening.
- ≥ Grade 2 bleeding within the past 30 days prior to screening, or requiring long-term anticoagulants treatment.
- Inadequate washing time for previous treatment.
- Previously treated with CAR-T cell products or genetically modified T cell therapies.
- Pregnant or lactating women.
- Severe central nervous system diseases or pathological changes.
- Malignancy history within 5 years prior to signing the ICF.
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 70 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.