NCT05169515

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Patients With B-Cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab or glofitamab in combination with CELMoDs (CC-220 and/or CC-99282) in participants with B-cell NHL.

Conditions

• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	SC Mosunetuzumab	Participants will receive SC mosunetuzumab for 12 cycles (cycle length = 21 days or 28 days for Cycle 1 and 28 days for Cycles 2-12)
DRUG	IV Glofitamab	Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days)
DRUG	Iberdomide	Arm 1: Participants will receive oral CC-220 from Day 1-21 of Cycle 2-12 (cycle length = 28 days for Cycles 2-12)
DRUG	Golcadomide	Arm 1: Participants will receive oral golcadomide from Day 1-14 starting in either Cycle 1 or Cycle 2 through Cycle 12 (cycle length = 28 days for cycles when golcadomide is to be administered) Arm 2: Participants will receive oral golcadomide from Day 1-10 starting in either Cycle 1, Cycle 2 or Cycle 3 through Cycle 12 (cycle length = 21 days)
DRUG	Obinutuzumab	Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)
DRUG	Tocilizumab	Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)

Timeline

• Start date: 2022-10-26
• Primary completion: 2029-09-15
• Completion: 2029-09-15
• First posted: 2021-12-27
• Last updated: 2026-03-19

Locations

26 sites across 5 countries: United States, Israel, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study