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)

May 2, 2024 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

836

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital Sydney
      • Wollongong, New South Wales, Australia, 2500
        • Wollongong Hospital; Cancer Care Centre
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Icon Cancer Care South Brisbane
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital; Haematology Clinical Trials
      • Fitzroy, South Australia, Australia, 3065
        • St. Vincent's Hospital Melbourne
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health Clinical Trial Pharmacy department
      • Melbourne, Victoria, Australia, 3124
        • The Alfred
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research Limited
      • Nedlands, Western Australia, Australia, 6009
        • The Perth Blood Institute
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H3
        • BC Cancer Agency Vancouver Centre - PARENT
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital; Department of Med Oncology
    • Quebec
      • Montréal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital; Research Unit
  • Germany
      • Bremen, Germany, 28239
        • DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie
      • Dortmund, Germany, 44137
        • St. Johannes Hospital; Abt. für Hämatologie und Onkologie
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Koln, Germany, 50931
        • Universitatsklinikum Koln; Apotheke Uniklinik Koln
      • Mainz, Germany, 55101
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
      • München, Germany, 81377
        • Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Würzburg, Germany, 97080
        • Universitatsklinikum Wurzburg
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d Hebron
      • Madrid, Spain, 280146
        • Hospital Universitario La Paz
      • Salamanca, Spain, 37007
        • Complejo asistencial universitario de Salamanca
    • Navarra
      • Pamplona, Navarra, Spain, 31620
        • Clinica Universidad de Navarra
  • United Kingdom
      • London, United Kingdom, E1 2AT
        • Barts Cancer Institute
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital; Institute of Cancer Research; Pharmacy Stores
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • La Jolla, California, United States, 92037
        • University of California San Diego Moores Cancer Center
      • Santa Barbara, California, United States, 93105
        • Sansum Medical Clinic, Inc.
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University School Of Medicine
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University; Wash Uni. Sch. Of Med
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center - Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Cancer Center at Westchester
      • New York, New York, United States, 10016
        • New York Uni Medical Center
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Willamette Valley Cancer Insitute and Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania; School of Medicine
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology - Nashville
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
Participants will receive BTCT4465A (Mosunetuzumab) via intravenous (IV) infusion or subcutaneous (SC) injection as a single-agent or in combination with atezolizumab. Dose escalation will be guided by the observed incidence of DLTs at each dose level.
Drug: BTCT4465A (Mosunetuzumab) IV
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
Drug: Atezolizumab
Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
Other Names:
  • Tecentriq
Drug: BTCT4465A (Mosunetuzumab) SC
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.
Experimental: Dose Expansion
Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.
Drug: BTCT4465A (Mosunetuzumab) IV
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
Drug: Atezolizumab
Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
Other Names:
  • Tecentriq
Drug: BTCT4465A (Mosunetuzumab) SC
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab)
Time Frame: BTCT4465A (Mosunetuzumab) single agent: Cycle 1; BTCT4465A (Mosunetuzumab) in combination with atezolizumab: during the first cycle that BTCT4465A (Mosunetuzumab) and atezolizumab are administered concurrently (cycle length = 21 days)
BTCT4465A (Mosunetuzumab) single agent: Cycle 1; BTCT4465A (Mosunetuzumab) in combination with atezolizumab: during the first cycle that BTCT4465A (Mosunetuzumab) and atezolizumab are administered concurrently (cycle length = 21 days)
Percentage of Participants With Adverse Events
Time Frame: Cycle 1 Day 1 until 90 days after the last infusion (cycle length = 21 days; up to approximately 14 months)
Cycle 1 Day 1 until 90 days after the last infusion (cycle length = 21 days; up to approximately 14 months)
BTCT4465A (Mosunetuzumab) Serum Concentration
Time Frame: Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
Atezolizumab Serum Concentration
Time Frame: Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
Percentage of Participants with Complete Response as Assessed Using Standard Criteria for NHL
Time Frame: Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)
Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response as Assessed Using Standard Criteria for NHL
Time Frame: Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)
Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)
Progression-Free Survival (PFS) as Assessed Using Standard Criteria for NHL
Time Frame: Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, withdrawal, or death from any cause)
Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, withdrawal, or death from any cause)
Overall Survival
Time Frame: Baseline until death from any cause (up to approximately 4 years)
Baseline until death from any cause (up to approximately 4 years)
European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Scores to Assess Health-Related Quality of Life (HRQoL)
Time Frame: Baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years).
The Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) Subscale, and the EuroQol 5 Dimension-5 Level (EQ-5D-5L) Questionnaire scores will also be used to assess HRQoL
Baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years).
Objective Response Rate (ORR)
Time Frame: Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)
Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2015

Primary Completion (Estimated)

November 15, 2025

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimated)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO29781

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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