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
Single group
CD19 and BCMA-targeted allogeneic CAR-T cells
GeneticLymphodepletion chemotherapy followed by CD19 and BCMA-targeted allogeneic CAR-T cells infusion
The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)
To characterize the safety of RN1201 Cells for Antibody-mediated Diseases
Objective Response Rate (ORR)
The responses will be assessed based on changes of platelet count and incidence of bleeding events, according to predefined response criteria
Pharmacokinetic (PK) of RN1201
Levels of RN1201 CAR-positive T cells in the blood and/or bone marrow
Pharmacodynamic (PD)-B cell depletion
Levels of B cells (direct and indirect measures) in the blood and/or bone marrow
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The First Affiliated Hospital of Soochow University
Lead sponsor
Allorunning Therapeutics
Collaborator
