A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
B-cell Non-Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for B-cell Non-Hodgkin Lymphoma
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham School of MedicineRecruiting
- City of HopeRecruiting
- University of Colorado Hospital - Anschutz Cancer PavilionRecruiting
- University of Miami Miller School of MedicineRecruiting
- Moffitt Cancer CenterRecruiting
- University of Michigan Hospital
- Karmanos Cancer InstituteRecruiting
- New York University Langone Medical CenterRecruiting
- Levine Cancer InstituteRecruiting
- Penn State Milton S. Hershey Medical CenterRecruiting
- Fox Chase Cancer Center
- University of Pittsburgh - Hillman Cancer CenterRecruiting
- Lifespan Cancer InstituteRecruiting
- University of Texas M.D. Anderson Cancer CenterRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
- Medical College of Wisconsin, Froedtert Hospital;Nephrology Section
- UZ Brussel
- CH Jolimont - Lobbes (Jolimont)
- Clinique St Pierre asbl
- Hamilton Health Sciences - Juravinski Cancer Centre
- Jewish General HospitalRecruiting
- Saskatchewan Cancer Agency (SCA) - Saskatoon Cancer Centre (SCC)
- Institut Catala d Oncologia Hospital Duran i ReynalsRecruiting
- Hospital de San Pedro de AlcantaraRecruiting
- Hospital General Universitario Gregorio MarañonRecruiting
- Hospital Infanta Leonor; Servicio de HematologiaRecruiting
- Hospital Universitario Virgen Macarena; Servicio de OncologiaRecruiting
- Cambridge University Hospitals NHS Foundation TrustRecruiting
- Plymouth Hospitals NHS Trust; Pharmacy DeptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Dose Finding
Mosunetuzumab + Polatuzumab Vedotin 2L+ R/R FL
Mosunetuzumab + Polatuzumab Vedotin 2L+R/R DLBCL
Mosunetuzumab SC + Polatuzumab Vedotin 3L+R/R MCL
Mosunetuzumab SC + Polatuzumab Vedotin 2L+R/R DLBCL
Participants will receive mosunetuzumab in combination with polatuzumab vedotin. Dose finding will be guided by the observed incidence of dose-limiting toxicities (DLTs) at each dose level.
Participants with at least one line of prior therapy (2L+) and that have relapsed or refractory (R/R) follicular lymphoma (FL) will receive mosunetuzumab + polatuzumab vedotin.
2L+ participants with R/R diffuse large B-cell lymphoma will receive mosunetuzumab + polatuzumab vedotin.
Participants with at least 2 lines of prior therapy (3L+) will receive subcutaneous (SC) mosunetuzumab + polatuzumab vedotin.
2L+ participants with R/R DLBCL will receive SC mosunetuzumab and polatuzumab vedotin.