Actively Recruiting
A Phase Ib, Open-Label Study Evaluating Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab Combined with CC-220 and/or CC-99282 in Adults with B-Cell Non-Hodgkin Lymphoma
Led by Hoffmann-La Roche · Updated on 2026-05-18
121
Participants Needed
26
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes mosunetuzumab or glofitamab when combined with CELMoDs (CC-220 and/or CC-99282) in adults with B-cell Non-Hodgkin Lymphoma (NHL). This Phase 1b study focuses on participants who have experienced relapse or did not respond to prior treatments, aiming to understand how these drug combinations work in this condition. Participants are randomly assigned to one of two groups. One group receives subcutaneous mosunetuzumab with either CC-220 or CC-99282, while the other receives intravenous glofitamab combined with CC-99282. Some receive oral treatments (Iberdomide or Golcadomide) on specific cycles, and one group gets pre-treatment with intravenous obinutuzumab. Treatment cycles last 12 rounds, with cycle lengths varying by drug and arm. Tocilizumab may be given as needed to manage side effects related to immune response. During the study, participants undergo regular assessments including scans and laboratory tests to monitor response and safety, using Lugano 2014 criteria for tumor evaluation. Researchers track side effects, dose changes, and drug levels in the blood over time, up to two years after treatment starts. The study carefully observes participants for adverse events and overall treatment tolerability, aiming to gather detailed information on how these drug combinations affect the disease and participant health.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Histologically confirmed hematologic malignancy expressing CD20 antigen
- For dose escalation: relapsed or refractory after at least two prior systemic therapies
- For dose expansion: follicular lymphoma Grades 1-3a relapsed or refractory after at least one prior systemic therapy and requiring systemic therapy
- For dose expansion: diffuse large B-cell lymphoma (DLBCL) or transformed follicular lymphoma relapsed or refractory after at least one prior systemic therapy
- DLBCL/transformed FL patients with one prior therapy must be ineligible for or refuse autologous stem cell transplantation or chimeric antigen receptor T-cell therapy
- PET-positive lymphoma with measurable nodal or extranodal lesions
- Availability of tumor specimen and pathology report for NHL diagnosis confirmation
- Preferred fresh pretreatment biopsy during screening
- Adequate blood counts without recent growth factors or transfusion
- Normal laboratory values
- Agreement to pregnancy prevention measures for females of childbearing potential and males during treatment and specified periods after last doses
You will not qualify if you...
- Pregnancy or breastfeeding, or intending pregnancy during study and specified post-treatment periods
- Prior therapy with cereblon-modulating drugs within 4 weeks before starting CC-220 and/or CC-99282
- Inability to swallow pills or persistent diarrhea/malabsorption Grade 2 or higher despite treatment
- QTc interval longer than 470 ms
- Prior treatments including mosunetuzumab, glofitamab, CD20/CD3 bispecific antibodies, allogenic stem cell therapy, or solid organ transplant
- Recent radiotherapy, autologous stem cell transplant, CAR T-cell therapy, monoclonal antibodies, radioimmunoconjugates, immunosuppressive medications, or other anti-cancer therapies within defined timeframes
- Recent live attenuated vaccine within 4 weeks before first dose or anticipated during study or within 5 months after final dose
- Current or past central nervous system lymphoma or leptomeningeal infiltration
- History of severe allergic reactions to monoclonal antibody therapy
- History of autoimmune diseases including myocarditis, pneumonitis, myasthenia gravis, and others
- Major surgery or significant trauma within 28 days before enrollment or planned during study
- Unresolved significant toxicities from prior treatments except as allowed
- Significant concomitant diseases affecting protocol compliance or results
- For glofitamab cohort: refractory to obinutuzumab monotherapy within 6 months before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 cycles (21 to 28 days per cycle)
Participants receive study drugs including subcutaneous mosunetuzumab or intravenous glofitamab combined with CC-220 and/or CC-99282 over multiple cycles.
Up to 12 visits corresponding to treatment cycles
Duration - Up to 90 days after the final dose
Participants are monitored for safety and efficacy outcomes after the final dose of study treatment.
Visits as needed for safety monitoring
Trial Site Locations
Total: 26 locations
1
UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program
San Francisco, California, United States, 94143
Actively Recruiting
2
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
6
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
Soroka
Beersheba, Israel, 0084101
Actively Recruiting
8
Rambam Health Care Campus
Haifa, Israel, 3109600
Actively Recruiting
9
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel, 9112001
Actively Recruiting
10
Center Hospital
Ramat Gan, Israel, 5262199
Actively Recruiting
11
Sourasky Medical Center
Tel Aviv, Israel, 6423900
Actively Recruiting
12
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
13
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, Emilia-Romagna, Italy, 47014
Actively Recruiting
14
ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy, 25123
Actively Recruiting
15
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
16
Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia
Pisa, Piedmont, Italy, 56126
Actively Recruiting
17
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
18
Hospital Universitario La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
19
Hospital Universitari Vall d Hebron
Barcelona, Spain, 08035
Actively Recruiting
20
Clinica Universidad de Navarra-Madrid
Madrid, Spain, 28027
Actively Recruiting
21
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28040
Actively Recruiting
22
Hosp Universitario Salamanca
Salamanca, Spain, 37007
Actively Recruiting
23
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
24
University College London Hospitals
London, United Kingdom, W1T 7HA
Actively Recruiting
25
Nottingham University Hospitals City Campus
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
26
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
Research Team
R
Reference Study ID Number: CO43805 https://forpatients.roche.com/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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