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
NCT ID: NCT05169515
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
121 participants
INTERVENTIONAL
2022-10-26
2029-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Participants will receive subcutaneous (SC) mosunetuzumab + CC-220 (dose escalation only) or SC mosunetuzumab + CC-99282.
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)
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)
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)
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
Arm 2
Participants will receive intravenous (IV) glofitamab + CC-99282.
IV Glofitamab
Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days)
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)
Obinutuzumab
Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
Interventions
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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)
IV Glofitamab
Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days)
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)
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)
Obinutuzumab
Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
Soroka
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Center Hospital
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, Italy
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, Emilia-Romagna, Italy
ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia
Pisa, Piedmont, Italy
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario La Fe
Valencia, Valencia, Spain
Hospital Universitari Vall d Hebron
Barcelona, , Spain
Clinica Universidad de Navarra-Madrid
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hosp Universitario Salamanca
Salamanca, , Spain
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
University College London Hospitals
London, , United Kingdom
Nottingham University Hospitals City Campus
Nottingham, , United Kingdom
Oxford University Hospitals NHS Trust;Churchill Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: CO43805 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728
Email: [email protected]
Other Identifiers
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CO43805
Identifier Type: -
Identifier Source: org_study_id