Lymphocytic Leukemia, Chronic, Lymphoma, Non Hodgkin
Conditions
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.
Interventions
DRUGBTCT4465A (Mosunetuzumab) IV
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
DRUGAtezolizumab
Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
DRUGBTCT4465A (Mosunetuzumab) SC
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| BTCT4465A (Mosunetuzumab) Serum Concentration | Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months) |
| Atezolizumab Serum Concentration | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
| Overall Survival | 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) | 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 |
| 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) | — |
Countries
Australia, Canada, Germany, South Korea, Spain, United Kingdom, United States
Outcome results
None listed