RN1201 Injection in the Treatment of Antibody-Mediated Diseases

Exclusion Criteria

• •Exclusion: - specific for Refractory immune-mediated PTR:
• •1. Uncontrolled active infection
• •2. Active hepatitis B or C infection
• •3. Patient has HIV or syphilis infection
• •4. Patient is pregnant or breastfeeding
• •5. Patient has a history of allogeneic hematopoietic stem cell transplantation (allo-HSCT)
• •6. Conventional treatment for antibody-mediated disease is effective
• •7. According to the New York Heart Association (NYHA) classification, patients with Class III/IV cardiovascular dysfunction
• •8. Other contraindications that make participation in this study unsuitable.
• •Exclusion: - specific for Relapsed or Refractory Immune Thrombocytopenia
• •1. Patients with the following conditions at the screening visit: Neutrophil count \<1×10⁹/L; serum creatinine \>1.5× upper limit of normal (ULN); immunoglobulin G (IgG) \<5 g/L.
• •2. Subjects with Class III or IV heart failure according to the NYHA classification (see Appendix I)
• •3. Subjects with a history of epilepsy or other central nervous system diseases
• •4. Patients with active viral, bacterial or other infections requiring systemic treatment at the screening visit (including active or latent tuberculosis (TB) or SARS-CoV-2), or with a history of clinically significant recurrent infections (e.g., Bacillus infection);
• •5. Herpes or varicella-zoster virus infection within 12 weeks prior to the screening visit (particularly shingles);
• •6. Patients positive for HCV or HBsAg are excluded. HBcAb-positive patients are eligible only if HBsAg (regardless of anti-HBs status) and HBV DNA are negative;
• •7. Known history of primary or secondary immunodeficiency, or positive test results for HIV (ELISA and Western blot) at the screening visit;
• •8. Live vaccine or attenuated live vaccine administration within 4 weeks prior to the baseline visit;
• •9. Breastfeeding or pregnancy at the screening visit or prior to medication administration (positive serum or urine - β-hCG pregnancy test);
• •10. Females of childbearing potential and males whose partners are of childbearing potential must use medically approved contraception or abstain from sexual intercourse during the study treatment period and for at least 6 months after its completion. Females of childbearing potential must have a negative serum HCG test within 7 days before study enrollment and must not be breastfeeding;
• •11. History of malignancy, except for cured non-melanoma skin cancer, carcinoma in situ (e.g., cervical, breast, bladder, or prostate cancer), and tumors in complete remission for at least 3 years without evidence of recurrence;
• •12. Any severe and/or unstable pre-existing medical, psychiatric condition, or other disease that the investigator considers may interfere with the patient's efficacy, safety, informed consent, or compliance with the trial protocol;
• •13. Known hypersensitivity, intolerance, or contraindication to RN1201 or any excipients in the study drugs (including Fludarabine, Cyclophosphamide, and Tocilizumab), or a history of severe allergic reactions;
• •14. Participation in other investigational studies within 30 days prior to enrollment or within five half-lives of the study drug, whichever is longer.