drugset / Trial / 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

NCT04246086

Phase 1/2 Active not recruiting 237 enrolled Hoffmann-La Roche
RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2020-08-12
Primary completion
2030-09-06
Completion
2030-09-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified Oral
Subject Mosunetuzumab Monoclonal antibody Intravenous
Background Tocilizumab Monoclonal antibody Intravenous

Indications