Back to resultsA 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)
Primary Purpose
Lymphocytic Leukemia, Chronic, Lymphoma, Non Hodgkin
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BTCT4465A (Mosunetuzumab) IV
Atezolizumab
BTCT4465A (Mosunetuzumab) SC
Sponsored by
About this trial
This is an interventional treatment trial for Lymphocytic Leukemia, Chronic
Eligibility 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
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
Sites / Locations
- City of Hope National Medical Center
- University of California San Diego Moores Cancer Center
- Sansum Medical Clinic, Inc.
- Rocky Mountain Cancer Center
- Yale University School Of Medicine
- Washington University; Wash Uni. Sch. Of Med
- Hackensack University Medical Center
- Memorial Sloan Kettering Bergen
- Memorial Sloan Kettering Cancer Center - Commack
- Memorial Sloan-Kettering Cancer Center
- Memorial Sloan Kettering Cancer Center at Westchester
- New York Uni Medical Center
- Willamette Valley Cancer Insitute and Research Center
- University of Pennsylvania; School of Medicine
- Tennessee Oncology
- MD Anderson Cancer Center
- Fred Hutchinson Cancer Research Center
- St Vincent's Hospital Sydney
- Wollongong Hospital; Cancer Care Centre
- Icon Cancer Care South Brisbane
- Princess Alexandra Hospital
- Royal Adelaide Hospital; Haematology Clinical Trials
- St. Vincent's Hospital Melbourne
- Royal Hobart Hospital
- Monash Health Clinical Trial Pharmacy department
- The Alfred
- Linear Clinical Research Limited
- The Perth Blood Institute
- BC Cancer Agency Vancouver Centre - PARENT
- Princess Margaret Hospital; Department of Med Oncology
- Jewish General Hospital; Research Unit
- DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie
- St. Johannes Hospital; Abt. für Hämatologie und Onkologie
- Universitätsklinikum Heidelberg
- Universitatsklinikum Koln; Apotheke Uniklinik Koln
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
- Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
- Universitatsklinikum Munster
- Universitätsklinikum Würzburg
- Seoul National University Hospital
- Asan Medical Center
- Samsung Medical Center
- Clínica Universidad de Navarra
- Hospital Universitario Vall d Hebron
- Hospital Universitario La Paz
- Complejo Asistencial Universitario de Salamanca
- Barts Cancer Institute
- The Christie NHS Foundation Trust
- Royal Marsden Hospital; Institute of Cancer Research; Pharmacy Stores
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose Escalation
Dose Expansion
Arm Description
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.
Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab)
Percentage of Participants With Adverse Events
BTCT4465A (Mosunetuzumab) Serum Concentration
Atezolizumab Serum Concentration
Percentage of Participants with Complete Response as Assessed Using Standard Criteria for NHL
Secondary Outcome Measures
Duration of Response as Assessed Using Standard Criteria for NHL
Progression-Free Survival (PFS) as Assessed Using Standard Criteria for NHL
Overall Survival
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)
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
Objective Response Rate (ORR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02500407
Brief Title
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)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2015 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocytic Leukemia, Chronic, Lymphoma, Non Hodgkin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
836 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose Expansion
Arm Type
Experimental
Arm Description
Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.
Intervention Type
Drug
Intervention Name(s)
BTCT4465A (Mosunetuzumab) IV
Intervention Description
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
Intervention Type
Drug
Intervention Name(s)
BTCT4465A (Mosunetuzumab) SC
Intervention Description
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.
Primary Outcome Measure Information:
Title
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)
Title
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)
Title
BTCT4465A (Mosunetuzumab) Serum Concentration
Time Frame
Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
Title
Atezolizumab Serum Concentration
Time Frame
Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
Title
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)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Overall Survival
Time Frame
Baseline until death from any cause (up to approximately 4 years)
Title
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)
Description
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
Time Frame
Baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years).
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sansum Medical Clinic, Inc.
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Washington University; Wash Uni. Sch. Of Med
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
New York Uni Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Willamette Valley Cancer Insitute and Research Center
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
University of Pennsylvania; School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Wollongong Hospital; Cancer Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Icon Cancer Care South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital; Haematology Clinical Trials
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
State/Province
South Australia
ZIP/Postal Code
3065
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Monash Health Clinical Trial Pharmacy department
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Linear Clinical Research Limited
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
The Perth Blood Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
BC Cancer Agency Vancouver Centre - PARENT
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H3
Country
Canada
Facility Name
Princess Margaret Hospital; Department of Med Oncology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Jewish General Hospital; Research Unit
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie
City
Bremen
ZIP/Postal Code
28239
Country
Germany
Facility Name
St. Johannes Hospital; Abt. für Hämatologie und Onkologie
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitatsklinikum Koln; Apotheke Uniklinik Koln
City
Koln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31620
Country
Spain
Facility Name
Hospital Universitario Vall d Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Barts Cancer Institute
City
London
ZIP/Postal Code
E1 2AT
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Marsden Hospital; Institute of Cancer Research; Pharmacy Stores
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35803286
Citation
Budde LE, Sehn LH, Matasar M, Schuster SJ, Assouline S, Giri P, Kuruvilla J, Canales M, Dietrich S, Fay K, Ku M, Nastoupil L, Cheah CY, Wei MC, Yin S, Li CC, Huang H, Kwan A, Penuel E, Bartlett NL. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. 2022 Aug;23(8):1055-1065. doi: 10.1016/S1470-2045(22)00335-7. Epub 2022 Jul 5.
Results Reference
derived
PubMed Identifier
34914545
Citation
Budde LE, Assouline S, Sehn LH, Schuster SJ, Yoon SS, Yoon DH, Matasar MJ, Bosch F, Kim WS, Nastoupil LJ, Flinn IW, Shadman M, Diefenbach C, O'Hear C, Huang H, Kwan A, Li CC, Piccione EC, Wei MC, Yin S, Bartlett NL. Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients With Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491. doi: 10.1200/JCO.21.00931. Epub 2021 Dec 16.
Results Reference
derived
Learn more about this trial
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)
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