Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT07105735
Eligibility Criteria:
Inclusion Criteria
1. Voluntary signed informed consent demonstrating understanding of the study and willingness/ability to comply with all trial procedures.
2. Age ≥18 years; both sexes eligible.
3. Documented diagnosis of an autoimmune disease for ≥6 months at screening, including but not limited to immune thrombocytopenia (ITP), autoimmune hemolytic anemia (AIHA), systemic lupus erythematosus (SLE), immune-mediated necrotizing myopathy (IMNM), neuromyelitis optica spectrum disorder (NMOSD), multiple sclerosis (MS), myasthenia gravis (MG), etc.
4. Standard-of-care therapy for ≥8 weeks before screening without achieving complete remission or adequate disease control, with stable dose for \>2 weeks.
5. Subjects on corticosteroid monotherapy at screening must be receiving ≥7.5 mg/day prednisone (or equivalent).
6. Disease activity score meeting criteria for moderate-to-severe active disease.
7. Adequate bone-marrow reserve, coagulation, cardiopulmonary, hepatic, and renal function.
8. Agreement to use effective contraception for 24 months after study enrollment.
Exclusion Criteria
Subjects meeting any of the following cannot be enrolled:
1. Known hypersensitivity, allergy, intolerance, or contraindication to RN1201 or any study drug component (fludarabine, cyclophosphamide, tocilizumab) or history of severe allergic reactions.
2. Severe cardiovascular disease or organ failure.
3. Active or uncontrolled infection requiring IV antibiotics or evidence of severe active infection.
4. Significant bleeding tendency (e.g., Gastrointestinal bleeding, coagulopathy, hypersplenism).
5. Hepatitis C virus, HIV, or syphilis infection.
6. History of epilepsy or severe neurological disorders/pathology not attributable to autoimmune disease.
7. Malignancy within 2 years before screening, except adequately treated carcinoma in situ of skin, cervix, or lung or other non-active tumors.
8. Prior CAR-T therapy or other genetically modified T-cell therapy.
9. Prednisone (or equivalent) ≥100 mg/day for ≥14 days within 4 weeks before screening.
10. Pregnancy, lactation, or planned pregnancy within 2 years.
11. Any condition that, in the investigator's judgment, may increase subject risk or interfere with study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07105735
Study Brief:
Protocol Section:
NCT07105735