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Clinical Trials in the UK / NCT03671018
Active, not recruiting Phase 1/2

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

NCT03671018 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 1/2
Started
2018-09-25
Last updated
2024-11-29

Condition(s) studied

B-cell Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

Mosunetuzumab (IV)Mosunetuzumab (SC)Polatuzumab vedotinTocilizumabRituximab

Mosunetuzumab (IV): Participants will receive intravenous (IV) mosunetuzumab.

Mosunetuzumab (SC): Participants will receive subcutaneous (SC) mosunetuzumab.

Polatuzumab vedotin: Participants will receive IV polatuzumab vedotin.

Tocilizumab: Participants will receive IV tocilizumab as needed.

Rituximab: Participants will receive IV rituximab.

Study summary

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy (3L+) for the treatment of R/R mantle cell lymphoma (MCL) and in participants with 2L+ R/R DLBCL.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * ECOG PS of 0, 1, or 2 * Histologically confirmed FL, DLBCL, or MCL * Must have received at least one prior systemic treatment regimen containing an anti-CD20-directed therapy for DLBCL or FL * For MCL, participants must have received at least two prior systemic treatment regiments, which include 1) anti-CD20-directed therapy, 2) BTK inhibitor, and 3) anthracycline or bendamustine * Relapsed to prior regimen(s) after having a documented history of response (complete response \[CR\], CR unconfirmed \[CRu\], or partial response \[PR\]) of \>/= 6 months in duration from completion of regimen(s); or, refractory to any prior regimen, defined as no response to the prior therapy, or progression within 6 months of completion of the last dose of therapy * Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest dimension * Adequate hematologic, renal, and hepatic function Key Exclusion Criteria: * Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies * Prior treatment with polatuzumab vedotin * Current \> Grade 1 peripheral neuropathy * Prior use of any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate (ADC) within 4 weeks before first dose of study treatment * Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment * Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment * Autologous stem-cell transplantation (SCT) within 100 days prior to first study treatment administration * Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first study treatment administration * Prior allogeneic SCT * Prior solid organ transplantation * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) * Patients with history of confirmed progressive multifocal leukoencephalopathy (PML) * Current or past history of central nervous system (CNS) lymphoma or CNS disease * History of autoimmune disease

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
University of Alabama at Birmingham School of Medicine Birmingham Alabama
City of Hope Duarte California
University of Colorado Hospital - Anschutz Cancer Pavilion Aurora Colorado
University of Miami Miller School of Medicine Miami Florida
Moffitt Cancer Center Tampa Florida
University of Michigan Hospital Ann Arbor Michigan
Karmanos Cancer Institute Detroit Michigan
New York University Langone Medical Center New York New York
Levine Cancer Institute Charlotte North Carolina
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
Fox Chase Cancer Center Philadelphia Pennsylvania
University of Pittsburgh - Hillman Cancer Center Pittsburgh Pennsylvania
Lifespan Cancer Institute Providence Rhode Island
University of Texas M.D. Anderson Cancer Center Houston Texas
Fred Hutchinson Cancer Research Center Seattle Washington
Medical College of Wisconsin, Froedtert Hospital;Nephrology Section Milwaukee Wisconsin
UZ Brussel Brussels Belgium
CH Jolimont - Lobbes (Jolimont) Haine-Saint-Paul Belgium
Clinique St Pierre asbl Ottignies Belgium
Hamilton Health Sciences - Juravinski Cancer Centre Hamilton Ontario
Jewish General Hospital Montreal Quebec
Saskatchewan Cancer Agency (SCA) - Saskatoon Cancer Centre (SCC) Saskatoon Saskatchewan
Institut Catala d Oncologia Hospital Duran i Reynals Barcelona Spain
Hospital de San Pedro de Alcantara Cáceres Spain
Hospital General Universitario Gregorio Marañon Madrid Spain
Hospital Infanta Leonor; Servicio de Hematologia Madrid Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia Seville Spain
Cambridge University Hospitals NHS Foundation Trust Cambridge United Kingdom
Plymouth Hospitals NHS Trust; Pharmacy Dept Plymouth United Kingdom

On this site

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More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03671018 on ClinicalTrials.gov ↗ ← All trials in the UK