An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma

Roche

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Hodgkin Lymphoma, Follicular Lymphoma

Treatments: Other: Tocilizumab; Drug: Mosunetuzumab SC; Drug: Atezolizumab; Drug: Tiragolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05315713

CO43116

Details and patient eligibility

About

This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have received at least two previous lines of systemic therapy.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged >/= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Life expectancy of at least 12 weeks
• Histologically documented FL or DLBCL that has relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists (e.g., standard chemotherapy, ASCT, CAR T cells)
• At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or at least one bi-dimensionally measurable (> 1.0 cm) extranodal lesion
• Participants with FL (including trFL) for whom a bone marrow biopsy and aspirate can be collected
• Adequate hematologic and organ function

Exclusion criteria

• Received any of the following treatments prior to study entry: mosunetuzumab or other CD20/CD3-directed bispecific antibodies; tiragolumab or other anti-TIGIT agent; allogenic SCT; solid organ transplantation
• Currently eligible for autologous SCT
• Current or past history of CNS lymphoma or leptomeningeal infiltration
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
• Contraindication to atezolizumab (if applicable) or tocilizumab
• Clinically significant toxicities from prior treatment have not resolved to Grade </= 1 (per NCI CTCAE v5.0) prior to the first study drug administration with exceptions defined by the protocol
• Treatment-emergent immune-mediated adverse events associated with prior immunotherapeutic agents as defined by the protocol
• Evidence of any significant, concomitant disease as defined by the protocol
• Major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)
• Significant cardiac, pulmonary, CNS, or liver disease, or known active infections
• History of other malignancy that could affect compliance with the protocol or interpretation of results
• History of autoimmune disease with exceptions as defined in the protocol

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab

Experimental group

Description:

Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)

Treatment:

Drug: Tiragolumab

Drug: Mosunetuzumab SC

Other: Tocilizumab

Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV

Experimental group

Description:

Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)

Treatment:

Drug: Tiragolumab

Drug: Atezolizumab

Drug: Mosunetuzumab SC

Other: Tocilizumab