NCT02500407

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)

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 713 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphocytic Leukemia, Chronic
• Lymphoma, Non Hodgkin

Interventions

Type	Name	Description
DRUG	BTCT4465A (Mosunetuzumab) IV	Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
DRUG	Atezolizumab	Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
DRUG	BTCT4465A (Mosunetuzumab) SC	Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.

Timeline

• Start date: 2015-09-15
• Primary completion: 2024-05-21
• Completion: 2025-09-01
• First posted: 2015-07-16
• Last updated: 2025-09-12

Locations

35 sites across 7 countries: United States, Australia, Canada, Germany, South Korea, Spain, United Kingdom