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ACTIVE NOT RECRUITINGPhase1

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT05169515

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
SC Mosunetuzumab (drug), IV Glofitamab (drug), Iberdomide (drug), Golcadomide (drug)
How long the study runs
Study runs about 82 months (dates as stated)
About the drug or intervention
SC Mosunetuzumab — drug: 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) · IV Glofitamab — drug: Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days) · Iberdomide — 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) · Golcadomide — drug: 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) · Obinutuzumab — drug: Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days) · Tocilizumab — drug: Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
121
Started
2022-10-26
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for non-hodgkin lymphoma
  • • Phase1 - 121 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-hodgkin lymphoma

Where?

  • • Glasgow - NHS Greater Glasgow and Clyde
  • • London - University College London Hospitals
  • • Nottingham - Nottingham University Hospitals City Campus
  • • Oxford - Oxford University Hospitals NHS Trust - Churchill Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Non-Hodgkin Lymphoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD20have a negativeCD3related fusionPR

Treatment history

Treatments you must have had:

  • ✓ relapsed after or failed to respond to at least two prior lines of systemic therapy
  • ✓ of systemic therapy
  • ✓ of therapy must: Not be considered a c

What the study is looking for

  • ✓Age \>/= 18 years
  • ✓activity scale (ECOG) Performance Status of 0, 1, or 2
  • ✓Fluorodeoxyglucose-avid lymphoma (i.e. PET-positive lymphoma)
  • ✓Availability of a representative tumor specimen and the corresponding pathology report for confirmation of the...
  • ✓A fresh pretreatment biopsy during screening period, excisional or incisional, is preferred

Who cannot take part

  • ✗Participant has received prior therapy with cereblon (CRBN)-modulating drug (e.g., lenalidomide, avadomide/CC-122,...
  • ✗Inability to swallow pills, or persistent diarrhea or malabsorption \>= Grade 2 National Cancer Institute (NCI)...
  • ✗QTc interval of \> 470 ms
  • ✗The following treatments prior to study entry: mosunetuzumab, glofitamab, or other CD20/CD3-directed bispecific...
  • ✗Current or past history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
See the full criteria
Inclusion Criteria: * 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 Criteria: * 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)

Where Is This Study? (4 UK sites)

NHS Greater Glasgow and Clyde

Glasgow G12 0YN, United Kingdom

Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

University College London Hospitals

London W1T 7HA, United Kingdom

Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Nottingham University Hospitals City Campus

Nottingham NG5 1PB, United Kingdom

Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford OX3 7LE, United Kingdom

Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---
Data sourced from ClinicalTrials.gov · Last verified: 2026-08