NCT04246086

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma

A Phase Ib/II, Open-Label, Multicenter Study With a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+Len), and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Patients With Follicular Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 237 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Mosunetuzumab (IV)	Participants will receive IV mosunetuzumab as defined by the study protocol
DRUG	Tocilizumab	Participants will receive IV tocilizumab as needed for adverse reactions as defined by the study protocol
DRUG	Lenalidomide	Participants will receive oral lenalidomide as defined by the study protocol
DRUG	Mosunetuzumab (SC)	Participants will receive SC mosunetuzumab as defined by the study protocol

Timeline

• Start date: 2020-08-12
• Primary completion: 2030-09-06
• Completion: 2030-09-06
• First posted: 2020-01-29
• Last updated: 2026-03-19

Locations

26 sites across 5 countries: United States, China, France, Spain, United Kingdom

Regulatory

• FDA-regulated drug study