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

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: NCT04903197

Novartis Reference Number: CVAY736J12101

Last Update: Apr 12, 2022

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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.

Condition 
Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
Phase 
Phase 1
Overall status 
Recruiting
Start date 
Jan 24, 2022
Completion date 
Sep 01, 2025
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

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

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, but no more than 5 prior lines)
Must have measurable disease and ECOG of 0 to 2
Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy and be willing to undergo study required biopsies at screening and during therapy

Exclusion Criteria:

Baseline laboratory results outside of protocol defined ranges
Presence of history of central nervous system involvement by 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

Study Locations

United States
The Ohio State University James Cancer Hospital &
Recruiting
Columbus, 43210 - Ohio
Contact: Shayla Thompson (614-293-2268) - [email protected] - David A Bond
United States
MD Anderson Cancer Center
Recruiting
Houston, 77030 - Texas
Contact: (713-792-0007) Jason Westin
United States
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3004
Victoria
Australia
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Japan
Novartis Investigative Site
Recruiting
Koto ku, 135 8550
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 05505
-
Korea, Republic of
Spain
Novartis Investigative Site
Recruiting
Madrid, 28041
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]