Non Hodgkin Lymphoma Clinical Trial
A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
Summary
This is a Phase 1/2 dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a single agent and in combination with atezolizumab in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Eligibility Criteria
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
B-cell hematologic malignancies expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival
Adequate hepatic, hematologic, and renal function
Key Exclusion Criteria:
Pregnant or lactating women
Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug
Treatment with radiotherapy within 2 weeks prior to the first BTCT4465A (Mosunetuzumab) administration
Systemic immunosuppressive medication within 2 weeks prior to study drug
Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation
Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia
History of central nervous system (CNS) lymphoma or other CNS disease
Significant cardiovascular or pulmonary disease
Hepatitis B or C or human immunodeficiency virus (HIV)
Receipt of a live attenuated vaccine within 4 weeks prior to study drug
Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first BTCT4465A (Mosunetuzumab) administration
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There are 46 Locations for this study
Duarte California, 91010, United States
La Jolla California, 92037, United States
Santa Barbara California, 93105, United States
Denver Colorado, 80218, United States
New Haven Connecticut, 06519, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
Montvale New Jersey, 07645, United States
Commack New York, 11725, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10016, United States
Springfield Oregon, 97477, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Seattle Washington, , United States
Darlinghurst New South Wales, 2010, Australia
Wollongong New South Wales, 2500, Australia
South Brisbane Queensland, 4101, Australia
Woolloongabba Queensland, 4102, Australia
Adelaide South Australia, 5000, Australia
Fitzroy South Australia, 3065, Australia
Hobart Tasmania, 7000, Australia
Clayton Victoria, 3168, Australia
Melbourne Victoria, 3124, Australia
Nedlands Western Australia, 6009, Australia
Nedlands Western Australia, 6009, Australia
Vancouver British Columbia, V5Z 1, Canada
Toronto Ontario, M5G 2, Canada
Montréal Quebec, H3T 1, Canada
Bremen , 28239, Germany
Dortmund , 44137, Germany
Heidelberg , 69120, Germany
Koln , 50931, Germany
Mainz , 55101, Germany
München , 81377, Germany
Münster , 48149, Germany
Würzburg , 97080, Germany
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Pamplona Navarra, 31620, Spain
Barcelona , 08035, Spain
Madrid , 28014, Spain
Salamanca , 37007, Spain
London , E1 2A, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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