Non Hodgkin Lymphoma Clinical Trial
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Activity of Tiragolumab in Participants With Relapsed or Refractory Multiple Myeloma or With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
This is a Phase I open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary activity of tiragolumab administered as a single agent or in combination with atezolizumab and/or daratumumab or rituximab in participants with relapsed or refractory (R/R) multiple myeloma (MM) or R/R non-Hodgkin lymphoma (NHL).
In the Phase Ia part of the study, tiragolumab is administered as a single agent in participants with R/R MM or R/R NHL.
In the Phase Ib part of the study, tiragolumab is administered in combination with atezolizumab and/or daratumumab in participants with R/R MM or with rituximab in participants with R/R NHL.
General Inclusion Criteria (All Participants):
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of >/= 12 weeks
Inclusion Criteria Specific to Arms A, C and E (R/R MM):
Arm A only: Must have R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
Arms C and E only: Participants with R/R MM who have received at least 3 prior lines of therapy.
Measurable disease defined by laboratory test results.
Inclusion Criteria Specific to Arms B and D (R/R NHL):
Participants with histologically confirmed B-cell NHL who have 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.
Must have at least one bi-dimensionally measurable lesion.
General Exclusion Criteria (All Participants):
Any anti-cancer therapy, whether investigational or approved, including chemotherapy, monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, hormonal therapy, and/or radiotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment
Prior treatment with any anti-TIGIT agent
Prior treatment with chimeric antigen receptor-T (CAR-T) therapy within 12 weeks before first study drug administration
Autologous Stem-Cell Transplantation (ASCT) within 100 days prior to first study drug administration
Active or history of autoimmune disease or immune deficiency
Known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection within 4 weeks prior to first study drug administration
Exclusion Criteria Specific to Arms A, C and E (R/R MM):
Primary or secondary plasma cell leukemia
Current or history of CNS involvement by MM
Exclusion Criteria Specific to Arms B and D (R/R NHL):
Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
Current or history of CNS lymphoma
Current eligibility for ASCT
Other protocol defined inclusion/exclusion criteria could apply
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There are 13 Locations for this study
Denver Colorado, 80218, United States
Atlanta Georgia, 30322, United States
Baltimore Maryland, 21201, United States
Saint Louis Missouri, 63128, United States
Cincinnati Ohio, 45236, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37203, United States
Fairfax Virginia, 22031, United States
Seoul , 06351, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 137-8, Korea, Republic of
Seoul , 138-7, Korea, Republic of
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