Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone LymphomaPhase 1NCT04903197
Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma
A Phase 1 study testing VAY736 and lenalidomide in people with Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, run by Novartis Pharmaceuticals at 10 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
- What is being tested?
- VAY736 and lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 24 Jan 2022to 24 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
China2 sites
Novartis Investigative Site
Shanghai, 200032
Novartis Investigative Site
Tianjin, 300020
Italy2 sites
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Rozzano, MI, 20089
South Korea2 sites
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 05505
About this study
Official title: 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)
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.
Read the detailed description
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.
- Being tested
- VAY736, lenalidomide
- 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
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAY736Drug
Also called ianalumab
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.
lenalidomideDrug
Immune-modulatory agent that enhances activation of NK cells.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: VAY736 |
| Arm 1B | Experimental | VAY736 single agent dose expansion in patients with DLBCL. This arm was not conducted. Receives: 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). Receives: Drug: VAY736; Drug: lenalidomide |
| Arm 2B | Experimental | VAY736 + lenalidomide dose expansion in patients with DLBCL. This arm was not conducted. Receives: Drug: VAY736; Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of dose limiting toxicities (DLTs)
Safety and tolerability
Measured: 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.
Measured: 4 years
Number of patients with dose interruptions and dose reductions
Safety and tolerability
Measured: 4 years
Dose intensity
Safety and tolerability
Measured: 4 years
Secondary outcomes (5)
Overall response rate (ORR)
Efficacy will be assessed by Lugano Classification (FDG-PET/CT scans)
Measured: 4 years
Best overall response (BOR) rate
Efficacy will be assessed by Lugano Classification (FDG-PET/CT scans)
Measured: 4 years
Area under curve (AUC) for VAY736 and combination partners
PK parameters will be derived from serum concentrations
Measured: 4 years
Maximum observed drug concentration after single dose administration (Cmax) for VAY736 and combination partners
PK parameters will be derived from serum concentrations
Measured: 4 years
Change from baseline in anti-drug antibodies (ADA)
Blood samples will be collected to detect change in levels of antibodies to VAY736
Measured: Baseline, 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start24 Jan 2022
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Why it stopped: Business decision and not due to any safety or tolerability concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone LymphomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Institutes of Biomedical Research, Study director, Novartis Institutes of Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903197
- Sponsor's protocol ID
- CVAY736J12101
- Other IDs
- 2020-005881-32
- Status last verified
- Mar 2026
- First submitted
- 25 May 2021
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT04903197
- Acronym / sponsor ID
- CVAY736J12101
- Keywords
- VAY736, ianalumab, lenalidomide, non-Hodgkin lymphoma, NHL, Diffuse large B cell lymphoma, DLBCL, Follicular lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision and not due to any safety or tolerability concerns.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1A | Experimental | Drug: VAY736VAY736 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) |
| Arm 1B | Experimental | Drug: VAY736VAY736 single agent dose expansion in patients with DLBCL. This arm was not conducted. |
| Arm 2A | Experimental | Drug: VAY736, Drug: lenalidomideVAY736 + lenalidomide dose escalation in patients with DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). |
| Arm 2B | Experimental | Drug: VAY736, Drug: lenalidomideVAY736 + lenalidomide dose expansion in patients with DLBCL. This arm was not conducted. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAY736Also: ianalumabVAY736 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 | Arm 1A, Arm 1B, Arm 2A, Arm 2B |
| lenalidomideImmune-modulatory agent that enhances activation of NK cells. | Drug | Arm 2A, Arm 2B |
Primary outcome
Incidence and nature of dose limiting toxicities (DLTs)
Time frame: 28 days (first cycle of treatment)
Safety and tolerability
Incidence of Adverse events (AEs) and serious adverse events (SAEs)
Time frame: 4 years
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.
Number of patients with dose interruptions and dose reductions
Time frame: 4 years
Safety and tolerability
Dose intensity
Time frame: 4 years
Safety and tolerability
5 secondary outcomes
Overall response rate (ORR)
Time frame: 4 years
Best overall response (BOR) rate
Time frame: 4 years
Area under curve (AUC) for VAY736 and combination partners
Time frame: 4 years
Maximum observed drug concentration after single dose administration (Cmax) for VAY736 and combination partners
Time frame: 4 years
Change from baseline in anti-drug antibodies (ADA)
Time frame: Baseline, 4 years
Results and safety
The study was stopped early (reason given: Business decision and not due to any safety or tolerability concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- CVAY736J12101 Clinical Trial ResultsLink provided by the sponsor.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Institutes of Biomedical Research study director
Novartis Institutes of Biomedical Research
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VAY736 and lenalidomide in people with Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, run by Novartis Pharmaceuticals at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, Italy, South Korea, Australia, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision and not due to any safety or tolerability concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and nature of dose limiting toxicities (DLTs) (time frame: 28 days (first cycle of treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.