Study of Mosunetuzumab or Glofitamab with CC-220 and/or CC-99282 for Non-Hodgkin Lymphoma
This study is looking at the safety and effectiveness of new drug combinations for people with B-cell Non-Hodgkin Lymphoma (a type of cancer that starts in white blood cells). Researchers are testing mosunetuzumab or glofitamab, given with CC-220 (iberdomide) and/or CC-99282 (golcadomide). These drugs are given either under the skin (subcutaneous, SC) or into a vein (intravenous, IV), and some are taken by mouth. To join, you must be at least 18 years old, have a certain performance status, and have a specific type of Non-Hodgkin Lymphoma that has returned or didn't respond to at least two previous treatments. The study will measure how many participants experience side effects and how many see their cancer shrink or disappear. The study plans to enroll 121 participants, but its current status is unclear.
- Study design
- This interventional study plans to enroll 121 participants. It will evaluate the safety and effectiveness of different drug combinations for Non-Hodgkin Lymphoma.
- What's involved
- Participants will receive study treatments for up to 12 cycles, with cycle lengths of 21 or 28 days. The specific drugs and how they are given will vary by arm.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for side effects for up to 90 days after their last study treatment. Their response to treatment will be assessed for up to 2 years after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentHoffmann-La Roche
~121 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:SC MosunetuzumabIV GlofitamabIberdomideGolcadomideObinutuzumabTocilizumab
At a glance
Recruiting sites
0 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with dose-limiting toxicities (DLTs) [dose escalation]
Measured over Until 90 days after the final dose of study treatment
+3 more outcomes measured
Conditions
Where it's being run
25 sites across 14 statesIsrael5
Spain4
United Kingdom4
Emilia-Romagna2
California1
Colorado1
Florida1
Illinois1
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age \>/= 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
History of one of the following histologically documented hematologic malignancies that are expected to express the CD20 antigen: In the Dose Escalation phase, participants must have relapsed after or failed to respond to at least two prior lines of systemic therapy. In the Dose Expansion phase, participants with FL Grades 1-3a must have relapsed after or failed to respond to at least one prior line of systemic therapy and must require systemic therapy. Participants with DLBCL/transformed FL must have relapsed after or failed to respond to at least one prior systemic treatment regimen.
Participants with DLBCL/transformed FL who have received only one prior line of therapy must: Not be considered a candidate for autologous stem cell transplantation (ASCT) due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT; or be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) therapy due to reasons defined by the protocol
Fluorodeoxyglucose-avid lymphoma (i.e. PET-positive lymphoma)
At least one bi-dimensionally measurable nodal lesion (\> 1.5 cm in its largest dimension by diagnostic quality CT or PET/CT scan), or at least one bi-dimensionally measurable extranodal lesion (\> 1.0 cm in its largest dimension by diagnostic quality CT or PET/CT scan)
Availability of a representative tumor specimen and the corresponding pathology report for confirmation of the diagnosis of NHL
A fresh pretreatment biopsy during screening period, excisional or incisional, is preferred
Adequate hematologic function without growth factors or blood product transfusion within 14 days of first dose of study drug administration
Normal laboratory values
All participants and health care providers will be trained and counseled on pregnancy prevention. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 3 months after the final dose of mosunetuzumab, at least 18 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC-99282, 3 months after the last dose of tocilizumab (if applicable), whichever is longer
For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC- 99282, 2 months after the final dose of tocilizumab (if applicable), whichever is longer
Exclusion
Pregnancy or breastfeeding, or intention of becoming pregnant during the study (female participants of childbearing potential must have a negative serum pregancy test result within 14 days prior to initiation of the study treatment) or within 3 months after the final dose of mosunetuzumab, at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, whichever is longer, 28 days after the last dose of CC-220, 28 days after the last dose of CC-9282, 3 months after the final dose of tocilizumab, whichever is longer
Participant has received prior therapy with cereblon (CRBN)-modulating drug (e.g., lenalidomide, avadomide/CC-122, pomalidomide) \</= 4 weeks prior to starting CC-220 and/or CC-99282
Inability to swallow pills, or persistent diarrhea or malabsorption \>= Grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), despite medical management
QTc interval of \> 470 ms
The following treatments prior to study entry: mosunetuzumab, glofitamab, or other CD20/CD3-directed bispecific antibodies; allogenic stem cell therapy (SCT); solid organ transplantation
Treatments (investigational or approved) within the following time periods prior to initiation/first dose of study treatment: radiotherapy within 2 weeks; autologous SCT within 100 days; chimeric antigen receptor (CAR) T-cell therapy within 30 days; prior anti-lymphoma treatment with monoclonal antibodies or antibody-drug conjugates within 4 weeks; use of radioimmunoconjugates within 12 weeks; systemic immunosuppressive medications within 2 weeks; any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter
Live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment
Current or past history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
Major surgery or significant traumatic injury \< 28 days prior to enrollment (excluding biopsies) or anticipation of the need for major surgery during study treatment
Clinically significant toxicities from prior treatment have not resolved to Grade \</= 1 (per US national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5.0) prior to the first study drug administration with exceptions defined by the protocol
Evidence of any significant, concomitant disease (e.g. cardiovascular, pulmonary, liver, CVA or stroke, ILD, PML, infection, HLH etc) that could affect compliance with the protocol or interpretation of results
For participants enrolled into glofitamab cohort: documented refractoriness to an obinutuzumab monotherapy-containing regimen (defined as disease that did not achieve response (PR or CR) or progressed within 6 months of the last dose of an obinutuzumab-containing regimen)
What this trial measures
- Percentage of participants with dose-limiting toxicities (DLTs) [dose escalation]Until 90 days after the final dose of study treatment
- Percentage of participants with adverse events [all cohorts]Until 90 days after the final dose of study treatment
- Best overall response rate (ORR), defined as the proportion of participants whose best overall response is a partial response (PR) or a complete response (CR) during the study, as determined by the investigator using Lugano 2014 criteria [dose expansion]Up to 2 years after start of primary study treatment
- Tolerability, as assessed by the incidence of dose interruptions, dose reductions, dose intensity, and treatment discontinuation [dose escalation]Until 90 days after the final dose of study treatment