This Phase 1, open-label study evaluates the safety, tolerability, and preliminary efficacy of RXIM002, a CD19-targeting circular RNA-mediated in-vivo CAR T-cell therapy, in adults with severe, relapsed, or refractory B cell-mediated autoimmune diseases.
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Incidence and severity of Dose-Limiting Toxicities (DLTs)
Timeframe: 28 days after RXIM002 first infusion (Day 1)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Timeframe: 52 weeks after RXIM002 first infusion (Day 1)
CAR positive cell Cmax
Timeframe: 24 weeks after RXIM002 first infusion (Day 1)
CAR positive cell Tmax
Timeframe: 24 weeks after RXIM002 first infusion (Day 1)
CAR positive cell AUC
Timeframe: 24 weeks after RXIM002 first infusion (Day 1)