Lymphocytic Leukemia, Chronic Clinical Trial
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
Verified date | May 2024 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 836 |
Est. completion date | November 15, 2025 |
Est. primary completion date | November 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital; Haematology Clinical Trials | Adelaide | South Australia |
Australia | Monash Health Clinical Trial Pharmacy department | Clayton | Victoria |
Australia | St Vincent's Hospital Sydney | Darlinghurst | New South Wales |
Australia | St. Vincent's Hospital Melbourne | Fitzroy | South Australia |
Australia | Royal Hobart Hospital | Hobart | Tasmania |
Australia | The Alfred | Melbourne | Victoria |
Australia | Linear Clinical Research Limited | Nedlands | Western Australia |
Australia | The Perth Blood Institute | Nedlands | Western Australia |
Australia | Icon Cancer Care South Brisbane | South Brisbane | Queensland |
Australia | Wollongong Hospital; Cancer Care Centre | Wollongong | New South Wales |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Canada | Jewish General Hospital; Research Unit | Montréal | Quebec |
Canada | Princess Margaret Hospital; Department of Med Oncology | Toronto | Ontario |
Canada | BC Cancer Agency Vancouver Centre - PARENT | Vancouver | British Columbia |
Germany | DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie | Bremen | |
Germany | St. Johannes Hospital; Abt. für Hämatologie und Onkologie | Dortmund | |
Germany | Universitätsklinikum Heidelberg | Heidelberg | |
Germany | Universitatsklinikum Koln; Apotheke Uniklinik Koln | Koln | |
Germany | Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | |
Germany | Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III | München | |
Germany | Universitatsklinikum Munster | Münster | |
Germany | Universitätsklinikum Würzburg | Würzburg | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Spain | Hospital Universitario Vall d Hebron | Barcelona | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Clínica Universidad de Navarra | Pamplona | Navarra |
Spain | Complejo Asistencial Universitario de Salamanca | Salamanca | |
United Kingdom | Barts Cancer Institute | London | |
United Kingdom | The Christie NHS Foundation Trust | Manchester | |
United Kingdom | Royal Marsden Hospital; Institute of Cancer Research; Pharmacy Stores | Sutton | |
United States | Memorial Sloan Kettering Cancer Center - Commack | Commack | New York |
United States | Memorial Sloan-Kettering Cancer Center | Commack | New York |
United States | Rocky Mountain Cancer Center | Denver | Colorado |
United States | City of Hope National Medical Center | Duarte | California |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Memorial Sloan Kettering Cancer Center at Westchester | Harrison | New York |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | University of California San Diego Moores Cancer Center | La Jolla | California |
United States | Memorial Sloan Kettering Bergen | Montvale | New Jersey |
United States | Tennessee Oncology - Nashville | Nashville | Tennessee |
United States | Yale University School Of Medicine | New Haven | Connecticut |
United States | New York Uni Medical Center | New York | New York |
United States | University of Pennsylvania; School of Medicine | Philadelphia | Pennsylvania |
United States | Washington University; Wash Uni. Sch. Of Med | Saint Louis | Missouri |
United States | Sansum Medical Clinic, Inc. | Santa Barbara | California |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Willamette Valley Cancer Insitute and Research Center | Springfield | Oregon |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States, Australia, Canada, Germany, Korea, Republic of, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab) | 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) | ||
Primary | Percentage of Participants With Adverse Events | Cycle 1 Day 1 until 90 days after the last infusion (cycle length = 21 days; up to approximately 14 months) | ||
Primary | BTCT4465A (Mosunetuzumab) Serum Concentration | Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months) | ||
Primary | Atezolizumab Serum Concentration | Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months) | ||
Primary | Percentage of Participants with Complete Response as Assessed Using Standard Criteria for NHL | 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 | Duration of Response as Assessed Using Standard Criteria for NHL | 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 | Progression-Free Survival (PFS) as Assessed Using Standard Criteria for NHL | 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) | ||
Secondary | Overall Survival | Baseline until death from any cause (up to approximately 4 years) | ||
Secondary | 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 | Baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years). | |
Secondary | Objective Response Rate (ORR) | 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) |
Status | Clinical Trial | Phase | |
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