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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
713
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.
University of California San Diego Moores Cancer Center
La Jolla, California, United States
Sansum Medical Clinic, Inc.
Santa Barbara, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
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)
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)
BTCT4465A (Mosunetuzumab) Serum Concentration
Time frame: 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)
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)
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)
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)
Overall Survival
Time frame: 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)
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).
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)
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