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
NCT05169515 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 121
Last updated 2026-05-18
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
Interventions
- 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
-
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
-
Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)
- DRUG
-
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-26
- Primary Completion
- 2029-09-15
- Completion
- 2029-09-15
- FDA Drug
- Yes
Countries
- United States
- Israel
- Italy
- Spain
- United Kingdom
Study Locations
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