Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This study will evaluate the safety, tolerability, pharmacokinetics, 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.
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment Eligibility
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