NCT06886919
Clinical Study Evaluating the Safety and Efficacy of IC19 CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
Not Yet Recruiting · Early Phase 1 · Beijing Immunochina Medical Science & Technology Co., Ltd. · registry updated 2025-03-24
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This study is an open label, single arm exploratory clinical trial of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus. Patients who are still in an active state after systemic treatment using the standard treatment regimen specified in the treatment guidelines were selected to receive IC19 CAR-T cell single pulse infusion therapy.
Inclusion
- Subjects diagnosed with systemic lupus erythematosus who meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE;
- Prior to screening, treatment with glucocorticoids (sufficient or shock therapy) combined with immunosuppressants (cyclophosphamide, mycophenolate mofetil, antimalarial drugs, azathioprine, methotrexate, leflunomide, tacrolimus, cyclosporine, etc.) and at least one biological agent (rituximab, belimumab, tacrolizumab, etc.) must have been received for at least 2 months, and the dosage must be stable for more than 2 weeks. The disease should still be active or recur after disease remission.
- Oral corticosteroids need to meet the following conditions:
- Prednisone (or equivalent) ≥ 7.5 mg/day and ≤ 60 mg/day;
- When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for glucocorticoids.
- \. When screening, the disease activity score (SLEDAI-2000) should be ≥ 8 points; 4. During the screening period, it meets the criteria of being positive for anti nuclear antibodies (ANAs), anti dsDNA antibodies, or anti Smith antibodies.
Exclusion
- Diseases of the central nervous system that have clinical significance in the past or during screening, such as seizures, epilepsy, epileptic seizures, cerebrovascular disease (ischemia/hemorrhage), cerebral edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, encephalitis, CNS vasculitis, or psychiatric disorders;
- Screening for acute severe lupus nephritis within the first 2 months, defined as significant deterioration of kidney disease (such as the presence of urine sediment and other laboratory abnormalities) that the researcher believes may require the use of contraindicated drugs or high-dose corticosteroids (prednisone ≥ 100 mg/d or equivalent corticosteroid treatment ≥ 14 days) for treatment in the first 2 months of the study.
- If there is an uncontrolled lupus crisis within the first 2 months of screening, the researcher has assessed that it is not suitable to participate in this study;
- A large amount of serous fluid accumulation (such as pleural effusion and peritoneal effusion) with compression symptoms that cannot be controlled after treatment;
- Other active autoimmune diseases (such as Crohn's disease and rheumatoid arthritis) that require systemic immunosuppressive therapy within the first 2 years of screening, except for SLE;
- Patients who have received or are waiting for hematopoietic stem cell/bone marrow transplantation or organ transplantation in the past;