An Open-Label, Multicenter, Phase Ib/II Trial Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Mosunetuzumab (BTCT4465A) In Combination With Polatuzumab Vedotin In Patients With B-Cell Non-Hodgkin Lymphoma

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Phase Ib-Specific Objectives:

Safety Objective:

To evaluate the safety, tolerability, pharmacokinetics, and efficacy of mosunetuzumab in combination with polatuzumab vedotin in patients with B-cell NHL

Phase II-Specific Objectives:

Primary Efficacy Objectives:

To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm I) in patients with R/R FL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm J) compared with polatuzumab vedotin plus bendamustine and rituximab in patients with R/R DLBCL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm F) compared with polatuzumab vedotin plus bendamustine and rituximab (Arm D)in patients with R/R DLBCL

Secondary Efficacy Objectives:

To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm I) in patients with R/R FL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm J) in patients with R/R DLBCL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm F) compared with mosunetuzumab alone (Arm E) and compared with polatuzumab vedotin plus bendamustine and rituximab (Arm D) in patients with R/R DLBCL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm F) compared with mosunetuzumab alone (Arm E) and compared with plus bendamustine followed by obinutuzumab polatuzumab vedotin plus bendamustine and rituximab (Arm D) in patients with R/R DLBCL

Safety Objectives:

To evaluate the safety of mosunetuzumab plus polatuzumab vedotin (Arm I) in patients with R/R FL
To evaluate the safety of mosunetuzumab plus polatuzumab vedotin (Arm J) in patients with R/R DLBCL
To evaluate the safety of mosunetuzumab plus polatuzumab vedotin compared with mosunetuzumab alone and compared with polatuzumab vedotin plus bendamustine and rituximab (Arm D) in patients with R/R DLBCL

Objectives for Both Phase Ib and Phase II:

Pharmacokinetic Objectives:

To characterize the pharmacokinetics of mosunetuzumab as a single agent and when administered in combination with polatuzumab

Immunogenicity Objectives:

Eligibility

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

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

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices