Non Hodgkin Lymphoma Clinical Trial
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
Summary
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.
Eligibility Criteria
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
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There are 15 Locations for this study
Los Angeles California, 90033, United States
Ann Arbor Michigan, 48109, United States
Providence Rhode Island, 02905, United States
Darlinghurst New South Wales, 2010, Australia
Box Hill Victoria, , Australia
Fitzroy Victoria, 3065, Australia
Brugge , 8000, Belgium
Bruxelles , 1000, Belgium
Kortrijk , 8500, Belgium
Yvoir , 5530, Belgium
Calgary Alberta, T2N 4, Canada
Toronto Ontario, M5G 1, Canada
Essen , 45122, Germany
Glasgow , G12 0, United Kingdom
London , SE3 6, United Kingdom
Plymouth , , United Kingdom
Sutton , SM2 5, United Kingdom
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