RN1201: a one-time CAR-T therapy for autoimmune diseases that haven’t responded to standard treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, open-label study evaluates the safety and feasibility of RN1201, an allogeneic CAR-T cell therapy, in adults with autoimmune diseases refractory to standard treatments. Participants receive lymphodepletion followed by a single RN1201 infusion and are monitored for dose-limiting toxicity and treatment-emergent adverse events. Secondary endpoints explore preliminary clinical responses and cell pharmacokinetics to gauge early signals of activity. The trial aims to determine whether RN1201 can be safely administered in this patient population and provide initial evidence of efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Lei Fan — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Lei Fan
• Email: fanlei@jsph.org.cn
• Phone: 086+025-68306124

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.