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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2026-03-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-12
Primary Completion
2030-09-06
Completion
2030-09-06
FDA Drug
Yes

Countries

  • United States
  • China
  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04246086 on ClinicalTrials.gov