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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.
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

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaUnknown status
Monash Health Clinical Trial Pharmacy department
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ClaytonAustraliaUnknown status
St Vincent's Hospital Sydney
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DarlinghurstAustraliaUnknown status
St Vincent's Hospital Melbourne
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FitzroyAustraliaUnknown status
Royal Hobart Hospital
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HobartAustraliaUnknown status
The Perth Blood Institute
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NedlandsAustraliaUnknown status
Icon Cancer Care South Brisbane
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South BrisbaneAustraliaUnknown status
Princess Alexandra Hospital
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WoolloongabbaAustraliaUnknown status
Jewish General Hospital
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MontrealCanadaUnknown status
Princess Margaret Hospital
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TorontoCanadaUnknown status
Universitätsklinikum Köln
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CologneGermanyUnknown status
Universitätsklinikum Heidelberg
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HeidelbergGermanyUnknown status
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
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MainzGermanyUnknown status
Klinikum der Universität München, Campus Großhadern
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MünchenGermanyUnknown status
Hospital Universitario Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Clínica Universidad de navarra
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PamplonaSpainUnknown status
Complejo Asistencial Universitario de Salamanca
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SalamancaSpainUnknown status
Barts Cancer Institute
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LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
Royal Marsden Hospital;Institute of Cancer Research
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SuttonUnited KingdomUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Memorial Sloan Kettering Cancer Center - Commack
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CommackUnited StatesUnknown status
Rocky Mountain Cancer Center
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DenverUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at Westchester
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HarrisonUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
University of California San Diego Moores Cancer Center
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La JollaUnited StatesUnknown status
Memorial Sloan Kettering Bergen
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MontvaleUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
New York Uni Medical Center
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New YorkUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Sansum Medical Clinic, Inc.
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Santa BarbaraUnited StatesUnknown status
Willamette Valley Cancer Insitute and Research Center
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SpringfieldUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.