Last Update: Mar 25, 2024
A Phase Ib, Multi-center, Open-label Dose Escalation and Expansion Platform Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (NHL)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CVAY736J12101
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK),
immunogenicity and preliminary efficacy of VAY736 alone or in combination with other
therapies in patients with NHL in a platform trial. 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 will be explored alone or in
combination with partner therapies. Increasing doses of VAY736 alone or in combination
will be given to small groups of patients to identify the MTD/RD in patients with NHL. In
dose expansion, some or all the treatments from dose escalation will be tested at the
recommended doses in patients with NHL. Combination partners may be added in the future
by protocol amendment. The study is expected to be approximately 4 years in duration
(from enrollment of first patient to discontinuation of last patient).

Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
Phase1
Recruiting
40
Jan 24, 2022
Oct 30, 2026
All
18 Years - (Adult, Older Adult)

Interventions

Drug

lenalidomide

Immune-modulatory agent that enhances activation of NK cells.
Drug

VAY736

VAY736 is a fully human IgG1 monoclonal antibody (mAb) which targets the B cell activating factor receptor (BAFF-R) expressed on the surface of differentiated B cells and modulates their function.

Eligibility Criteria

Inclusion Criteria:

- Adult patients with confirmed diagnosis of relapsed/refractory B-cell NHL with all
subtypes of DLBCL, follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle
cell lymphoma (MCL) per WHO 2016 criteria. Patients in subtype arm e.g. DLBCL must
have confirmed diagnosis of relapsed/refractory DLBCL.

- Received and failed or be intolerant to standard of care therapy (at least two prior
lines, including an anti-CD20 therapy for NHL)

- Must have measurable disease and ECOG of 0 to 2

Exclusion Criteria:

- Baseline laboratory results outside of protocol defined ranges

- Patients with primary CNS lymphoma

- History of hypersensitivity to VAY736 or any drugs in similar chemical classes (e.g.
monoclonal antibodies)

- Impaired cardiac function or clinically significant cardiac disease

- History of or current interstitial lung disease or pneumonitis grade 2 or higher

- HIV infection

- Active hepatitis C infection and/or hepatitis B infection

- Pregnant or nursing (lactating) women

- Women of child-bearing potential unless they are using highly effective methods of
contraception

Other Inclusion/Exclusion criteria may apply

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Novartis Pharmaceuticals