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, Multicentre, 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

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.

Trial Description

Primary Outcome:

• 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

• 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)
• Objective Response Rate (ORR)

View this trial on ClinicalTrials.gov