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)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
EXCLUSION CRITERIA
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Lymphocytic Leukemia, Chronic,Lymphoma, Non Hodgkin
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
836
Est. Completion Date
Nov 15, 2023
Treatment type
Interventional
Sponsor
Genentech, Inc.
ClinicalTrials.gov identifier
NCT02500407
Study number
GO29781
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