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Brief Title: Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL
Official Title: A Phase I/Ib Open-label, Multi-center Dose Escalation Study of JBH492 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
Study ID: NCT04240704
Brief Summary: The purpose of the First-In-Human study is to assess safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
Detailed Description: This is a FIH, open-label, phase I/Ib, multi-center study, which consists of a dose escalation part of JBH492 as a single agent, followed by an expansion part. The escalation part will be conducted in patients with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and Non-Hodgkin's Lymphoma (r/r NHL). Once the MTD/RD of single agent JBH492 is determined, the study will continue with an expansion part with single agent JBH492 in defined patient populations
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Novartis Investigative Site, Helsinki, , Finland
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Freiburg, , Germany
Novartis Investigative Site, Tel Aviv, , Israel
Novartis Investigative Site, Chuo ku, Tokyo, Japan
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Barcelona, Catalunya, Spain