Study of safety and preliminary efficacy of VAY736 given alone or in combination with other antineoplastic agents in patients with NHL

JRCT ID: jRCT2031210238

Registered date:13/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-Hodgiking Lymphoma
• Date of first enrollment: 12/09/2023
• Target sample size: 86
• Countries of recruitment: Australia,Japan,China,Japan,Germany,Japan,Italy,Japan,Rupublic of Korea,Japan,Singapore,Japan,Spain,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Dose Escalation Part
Arm 1A: For NHL, VAY736 i.v. Q2W single agent administration (the starting dose is 3mg/kg and dose escalation to MTD or RD).
Arm 2A: For NHL, VAY736 + lenalidomide 25mg PO QD for Day 1-21 (the starting dose of VAY736 is planned to be determined based on data from Arm 1A and in the discussion with investigators).
Dose Expansion Part
Arm 1B: For DLBCL, VAY736 single agent administration at the RD.
Arm 2B: For DLBCL, VAY736 at the RD + lenalidomide 25mg

Outcome(s)

Primary Outcome

Endpoints for primary objectives
Safety:
- Incidence and nature of DLTs
- Incidence and severity of AEs and serious adverse events (SAEs), changes in laboratory values, vital signs and ECGs
Tolerability:
- Dose interruptions, reductions and dose intensity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Adult patients with histologically confirmed diagnosis of B-cell NHL with all subtypes per WHO 2016 criteria. Patients in subtype arms e.g. diffuse large B-cell lymphoma (DLBCL) must have confirmed diagnosis of r/r 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 =< 2
- Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy and must be willing to undergo study required biopsies at screening and during therapy.

Exclude criteria

- Baseline laboratory results outside of protocol defined ranges.
- Presence or history of central nervous system involvement by lymphoma
- Ongoing immunosuppressive therapy for treatment of lymphoma
- History of hypersensitivity to VAY736 or any of its excipients or to drugs in similar chemical classes (e.g. mAb)
- Impaired cardiac function or clinically significant cardiac disease
- History of or current interstitial lung disease or pneumonitis >= Grade 2
- Human immunodeficiency virus (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

Related Information

• Primary Sponsor: Yonemura Masataka
• Secondary ID(s): NCT04903197