A Safety 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)



Status:Recruiting
Conditions:Blood Cancer, Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:September 30, 2015
End Date:September 2, 2019
Contact:Reference Study ID Number: GO29781 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

Use our guide to learn which trials are right for you!

An Open-Label, Multicenter, Phase I/IB Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BTCT4465A as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

This is a Phase 1/1b 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.


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
We found this trial at
18
sites
660 South Euclid Avenue
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Commack, New York 11725
?
mi
from
Commack, NY
Click here to add this to my saved trials
650 Commack Rd
Commack, New York 11725
(631) 623-4000
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
?
mi
from
Commack, NY
Click here to add this to my saved trials
Darlinghurst, New South Wales 2010
?
mi
from
Darlinghurst,
Click here to add this to my saved trials
Denver, Colorado 80218
?
mi
from
Denver, CO
Click here to add this to my saved trials
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
?
mi
from
Duarte, CA
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
500 Westchester Avenue
Harrison, New York 10604
?
mi
from
Harrison, NY
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
225 Summit Avenue
Montvale, New Jersey 07645
?
mi
from
Montvale, NJ
Click here to add this to my saved trials
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
333 East 38th Street
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Santa Barbara, California 93105
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
?
mi
from
Springfield, OR
Click here to add this to my saved trials