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

NCT04903197 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CVAY736J121012020-005881-32
• Study Type: interventional
• Target: 18
• Locations: 7 countries
• Sites: 10

Brief Summary

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.

Conditions

Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma

Keywords

VAY736; ianalumab; lenalidomide; non-Hodgkin lymphoma; NHL; Diffuse large B cell lymphoma; DLBCL; Follicular lymphoma; FL; Mantle cell lymphoma; MCL; Marginal zone lymphoma; MZL

Outcome Measures

Primary Outcomes (4)

• Incidence and nature of dose limiting toxicities (DLTs)

  Safety and tolerability

  28 days (first cycle of treatment)

• Incidence of Adverse events (AEs) and serious adverse events (SAEs)

  Incidence of AEs and SAEs is defined as number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.

  4 years

• Number of patients with dose interruptions and dose reductions

  Safety and tolerability

  4 years

• Dose intensity

  Safety and tolerability

  4 years

Secondary Outcomes (5)

• Overall response rate (ORR)

  4 years

• Best overall response (BOR) rate

  4 years

• Area under curve (AUC) for VAY736 and combination partners

  4 years

• Maximum observed drug concentration after single dose administration (Cmax) for VAY736 and combination partners

  4 years

• Change from baseline in anti-drug antibodies (ADA)

  Baseline, 4 years

Study Arms (4)

Arm 1A

EXPERIMENTAL

VAY736 single agent dose escalation in patients with NHL subtypes of diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL)

Drug: VAY736

Arm 1B

EXPERIMENTAL

VAY736 single agent dose expansion in patients with DLBCL. This arm was not conducted.

Drug: VAY736

Arm 2A

EXPERIMENTAL

VAY736 + lenalidomide dose escalation in patients with DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL).

Drug: VAY736; Drug: lenalidomide

Arm 2B

EXPERIMENTAL

VAY736 + lenalidomide dose expansion in patients with DLBCL. This arm was not conducted.

Drug: VAY736; Drug: lenalidomide

Interventions

VAY736 DRUG

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.

Also known as: ianalumab

Arm 1A; Arm 1B; Arm 2A; Arm 2B

lenalidomide DRUG

Immune-modulatory agent that enhances activation of NK cells.

Arm 2A; Arm 2B

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Melbourne, Victoria, 3004, Australia

Location

Novartis Investigative Site

Shanghai, 200032, China

Location

Novartis Investigative Site

Tianjin, 300020, China

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Rozzano, MI, 20089, Italy

Location

Novartis Investigative Site

Yamagata, Yamagata, 990 9585, Japan

Location

Novartis Investigative Site

Singapore, 119228, Singapore

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Seoul, 05505, South Korea

Location

Related Links

• CVAY736J12101 Clinical Trial Results
• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone

Interventions

ianalumab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Novartis Institutes of Biomedical Research

  Novartis Institutes of Biomedical Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 26, 2021
• Study Start: January 24, 2022
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (2); JP (1); KR (2); CN (2); AU (1); SG (1)