The purpose of the First-In-Human study was to assess the safety, tolerability,
pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04240704.
This was a FIH, open-label, phase I/Ib, multi-center study, which consisted of a dose
escalation part of JBH492 as a single agent, followed by an expansion part. The
escalation part was conducted in patients with relapsed/refractory chronic lymphocytic
leukemia (r/r CLL) and Non-Hodgkin's Lymphoma (r/r NHL). Once the maximum tolerated
dose/recommended dose (MTD/RD) of single agent JBH492 was determined, the study continued
with an expansion part with single agent JBH492 in defined patient populations.
Lead OrganizationNovartis Pharmaceuticals Corporation