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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

836

Study ID:

NCT02500407

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

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There are 53 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States
University of California San Diego Moores Cancer Center
La Jolla California, 92037, United States
Sansum Medical Clinic, Inc.
Santa Barbara California, 93105, United States
Rocky Mountain Cancer Center
Denver Colorado, 80218, United States
Yale University School Of Medicine
New Haven Connecticut, 06519, United States
Washington University; Wash Uni. Sch. Of Med
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Memorial Sloan Kettering Bergen
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center - Commack
Commack New York, 11725, United States
Memorial Sloan-Kettering Cancer Center
Commack New York, 11725, United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison New York, 10604, United States
New York Uni Medical Center
New York New York, 10016, United States
Willamette Valley Cancer Insitute and Research Center
Springfield Oregon, 97477, United States
University of Pennsylvania; School of Medicine
Philadelphia Pennsylvania, 19104, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, , United States
St Vincent's Hospital Sydney
Darlinghurst New South Wales, 2010, Australia
Wollongong Hospital; Cancer Care Centre
Wollongong New South Wales, 2500, Australia
Icon Cancer Care South Brisbane
South Brisbane Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Royal Adelaide Hospital; Haematology Clinical Trials
Adelaide South Australia, 5000, Australia
St. Vincent's Hospital Melbourne
Fitzroy South Australia, 3065, Australia
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia
Monash Health Clinical Trial Pharmacy department
Clayton Victoria, 3168, Australia
Peter MacCallum Cancer Centre-East Melbourne
Melbourne Victoria, 3000, Australia
The Alfred
Melbourne Victoria, 3124, Australia
Linear Clinical Research Limited
Nedlands Western Australia, 6009, Australia
The Perth Blood Institute
Nedlands Western Australia, 6009, Australia
BC Cancer Agency Vancouver Centre - PARENT
Vancouver British Columbia, V5Z 1, Canada
Princess Margaret Hospital; Department of Med Oncology
Toronto Ontario, M5G 2, Canada
Jewish General Hospital; Research Unit
Montréal Quebec, H3T 1, Canada
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille , 59037, France
CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme
Montpellier , 34295, France
CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique
Nantes , 44093, France
Hôpital St Louis - Service de Dermatologie II
Paris , 75010, France
Centre Hospitalier Lyon Sud
Pierre-Benite , 69495, France
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse , 31059, France
DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie
Bremen , 28239, Germany
St. Johannes Hospital; Abt. für Hämatologie und Onkologie
Dortmund , 44137, Germany
Universitätsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitatsklinikum Koln; Apotheke Uniklinik Koln
Koln , 50931, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz , 55101, Germany
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
München , 81377, Germany
Universitatsklinikum Munster
Münster , 48149, Germany
Universitätsklinikum Würzburg
Würzburg , 97080, Germany
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Clínica Universidad de Navarra
Pamplona Navarra, 31620, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario La Paz
Madrid , 28014, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca , 37007, Spain
Barts Cancer Institute
London , E1 2A, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Royal Marsden Hospital; Institute of Cancer Research; Pharmacy Stores
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

836

Study ID:

NCT02500407

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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