NCT02500407CompletedPhase 1/2
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)
An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (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
Source: ClinicalTrials.gov · Last updated 12 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 713 (actual)
- First submitted
- 14 Jul 2015
- Start date
- 15 Sept 2015
- Primary completion date
- 21 May 2024
- Lead sponsor
- Genentech, Inc.
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT02500407
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 713
- From 15 Sept 2015 to the primary completion date, 21 May 2024
- 35 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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)
Other
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Monash Health Clinical Trial Pharmacy department Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| St Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Royal Hobart Hospital Coordinator of this site? Confirm its status | Hobart | Australia | Unknown status |
| The Perth Blood Institute Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Icon Cancer Care South Brisbane Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Universitätsklinikum Köln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Universitätsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Klinikum der Universität München, Campus Großhadern Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Hospital Universitario Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Barts Cancer Institute Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Royal Marsden Hospital;Institute of Cancer Research Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Memorial Sloan Kettering Cancer Center - Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Rocky Mountain Cancer Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of California San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Memorial Sloan Kettering Bergen Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| New York Uni Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Sansum Medical Clinic, Inc. Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| Willamette Valley Cancer Insitute and Research Center Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.