RN1201 Injection in the Treatment of Antibody-Mediated Diseases

Conditions: Refractory Immune-mediated Platelet Transfusion Refractoriness, Relapsed or Refractory Immune Thrombocytopenia

Sex: All

Ages: 16 Years – 65 Years

Healthy volunteers: No

Phase: PHASE1

Enrollment: 9

Sponsor: The First Affiliated Hospital of Soochow University

Location: The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Summary

This single-arm, open-label exploratory trial aims to evaluate the safety, feasibility, and preliminary efficacy of RN1201 Injection in patients with antibody-mediated diseases, including refractory immune-mediated platelet transfusion refractoriness (PTR) and relapsed or refractory immune thrombocytopenia (ITP). Patients will receive RN1201 cells infusion following lymphodepletion. The study will assess safety, response rates, B-cell depletion, and immune reconstitution. Exploratory analyses will examine in vivo persistence and activity of RN1201.

Eligibility Criteria

Inclusion Criteria: Inclusion: - specific for Refractory immune-mediated PTR: 1. Aged 16-65 years 2. Diagnosed with refractory immune-mediated PTR 3. Resistant to at least 3 standard therapies 4. Able to understand the study and consent 5. Projected survival time exceeding three months 6. Left Ventricular Ejection Fraction (LVEF) ≥0.5 (as measured by echocardiogram) 7. Creatinine \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07072247). StuddyBuddy aggregates publicly available trial information.