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.
Aged 16-65 years
Diagnosed with refractory immune-mediated PTR
Resistant to at least 3 standard therapies
Able to understand the study and consent
Uncontrolled active infection
Active hepatitis B or C infection
Patient has HIV or syphilis infection
Patient is pregnant or breastfeeding
The First Affiliated Hospital of Soochow University
Lead sponsor
Allorunning Therapeutics
Collaborator