A Study Evaluating the Safety, Efficacy, and Pharmacokine... | NCT05207670

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A	Experimental	Participants with high tumor burden with untreated follicular lymphoma (FL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first. Participants that achieve complete or partial metabolic response will have the option of receiving maintenance therapy with mosunetuzumab every 8 weeks for 1 year.	Drug: Mosunetuzumab (Cohorts A-C) Drug: Tocilizumab
Cohort B	Experimental	Elderly participants with untreated diffuse large B-cell lymphoma (DLBCL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.	Drug: Mosunetuzumab (Cohorts A-C) Drug: Tocilizumab
Cohort C	Experimental	Participants with untreated marginal zone lymphoma (MZL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.	Drug: Mosunetuzumab (Cohorts A-C) Drug: Tocilizumab
Cohort D	Experimental	Participants with relapsed or refractory (R/R) mantle cell lymphoma (MCL) will receive SC mosunetuzumab monotherapy for up to 34 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mosunetuzumab (Cohorts A-C)	Drug	Participants will receive SC mosunetuzumab for up to 17 cycles and for optional maintenance (Cohort A only)	Cohort A Cohort B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS) rate at 24 months after the first study treatment (Cohorts A1, A2, and B)		From the first study treatment to the first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, as determined by the investigator according to Lugano Criteria 2014 (minimum 2 years)
Objective response rate (ORR), defined as the proportion of participants with a complete metabolic response (CMR) or partial response (PR), as determined by the investigator according to the Lugano Criteria 2014 (Cohorts C, D, and E)		Cycles 4, 8, 12 and 17 (cycle length=21 days)

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS) (all cohorts)		From first study treatment to death from any cause (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)
ORR, defined as the proportion pf participants with a CMR or PR, as determined by the investigator according to the Lugano Criteria 2014 (Cohorts A1, A2, and B)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least one bi-dimensionally measurable nodal lesion, defined as >1.5 cm in its longest dimension, or one bi-dimensionally measurable lesion, defined as >1.0 cm in its longest diameter by computed tomography (CT) scan, positivie emission tomography - computed tomography (PET- CT), or magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Adequate hematologic function
No active infection
Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/µL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
For women of childbearing potential (except those in Cohort B): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined by the protocol
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined by the protocol

Inclusion Criteria Specific to Cohorts A1 and A2

Inclusion Criteria Specific to Cohort B

Aged ≥ 80 years at the time of signing informed consent form (ICF), or aged 65-79 years and considered ineligible for chemoimmunotherapy (R-CHOP) with at least one of the following: Impairment in ≥ 2 Activities of Daily Living (ADL); impairment in ≥ 2 Instrumental Activities of Daily Living (IADL); or Cumulative Illness Rating Scale-Geriatric (CIRS-G) score of ≥ 1 comorbidity with a severity of 3-4 or a score of 2 in ≥ 8 comorbidities
Histologically confirmed DLBCL according to WHO 2016 classification expected to express the CD20 antigen (Swerdlow et al. 2016)
Previously untreated DLBCL with indication to start systemic therapy and are not eligible for curative therapy
High-grade B-cell lymphomas, not otherwise specified (HGBL NOS) and HGBL with MYC and B-cell lymphoma (BCL)-2 and/or BCL-6 rearrangements
Adequate end-organ function

Inclusion Criteria Specific to Cohort C

Histologically conformed MZL (splenic, nodal, and extra-nodal)
Previously untreated MZL with indication to start systemic therapy
Helicobacter pylori-positive disease that has remained stable, progressed, or relapsed following antibiotic therapy and requires therapy, as assessed by the investigator (for cases of gastric/MALT MZL)
Adequate renal function

Inclusion Criteria Specific to Cohort D

Histologically confirmed MCL
Relapsed after or failed to respond to at least one prior treatment regimen containing a Bruton's tyrosine kinase (BTK) inhibitor
Adequate renal function
Adverse events from prior anti-cancer therapy resolved to Grade \

Facility	Status	City	State	ZIP	Country	Contacts
Infirmary Cancer Care		Mobile	Alabama	36607-3513	United States
Alaska Oncology & Hematology, LLC

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases