Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma

The primary objective of the study is to evaluate the safety and tolerability in patients

with NHL and identify a maximum tolerated dose (MTD) and/or recommended dose (RD) of

VAY736 single agent and in combination with other anti-cancer therapies.

This is a phase I/Ib, multi-center, open-label study with multiple treatment arms in an

adaptive study design. The study is comprised of a dose escalation part and dose

expansion part.

In dose escalation, the investigational drug VAY736 was explored alone or in combination

with lenalidomide. Increasing doses of VAY736 alone or in combination were given to small

groups of patients to identify the maximum tolerated dose/recommended dose (MTD/RD) in

patients with NHL. In dose expansion, some or all the treatments from dose escalation

could be tested at the recommended doses in patients with NHL. The study was expected to

last approximately 4 years (from the enrollment of the first patient to the

discontinuation of the last patient), but it was terminated early due to a business

decision, not because of any safety or tolerability concerns. Consequently, the dose

expansion part was not conducted.