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

• Status: Recruiting
• Trial end date: 2024-04-15
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of intravenous mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL) and in participants with follicular lymphoma (FL). 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 for the treatment of R/R mantle cell lymphoma (MCL).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal; Bendamustine Hydrochloride; Cyclophosphamide; Doxorubicin; Immunoconjugates; Liposomal doxorubicin; Obinutuzumab; Prednisone; Rituximab; Vincristine

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