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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)

NCT02500407 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 713

Last updated 2025-09-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-15
Primary Completion
2024-05-21
Completion
2025-09-01

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500407 on ClinicalTrials.gov