A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
brief summary
The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
detailed description
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b/2a, open-label, sequential-cohort, dose escalation and expansion study will evaluate the safety, tolerability, PK, PD, and preliminary clinical effectiveness of budoprutug in subjects with ITP. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts of patients aged 18 years and above with a platelet count \< 30,000/µL despite an adequate trial of at least one prior therapeutic attempt.
official title
A Phase 1b/2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects With Immune Thrombocytopenia (ITP)