San Pedro Alcantara

Researchers are investigating budoprutug, a humanized immunoglobulin G1 monoclonal antibody targeting CD19, in adults with Immune Thrombocytopenia (ITP). This Phase 1b/2a, open-label, sequential-cohort study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of budoprutug. Participants have ITP with low platelet counts despite prior treatment attempts. Participants will receive budoprutug as two intravenous infusions given 14 days apart in escalating doses. The study includes dose escalation and expansion cohorts where the medication is given as a single IV dose on Day 1 and Day 15. The treatment is designed to deplete targeted cells through antibody-dependent cellular cytotoxicity. Throughout the study, researchers will monitor safety by tracking treatment-emergent adverse events up to week 48. Participants will undergo laboratory tests to confirm eligibility and monitor blood counts and other parameters. The study evaluates pharmacokinetics, pharmacodynamics, and clinical response while following participants for safety and tolerability over several weeks.