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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Participants will receive subcutaneous (SC) mosunetuzumab + CC-220 (dose escalation only) or SC mosunetuzumab + CC-99282. |
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| Arm 2 | Experimental | Participants will receive intravenous (IV) glofitamab + CC-99282. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Best CR rate, defined as the proportion of participants whose best overall response is a CR during the study, as determined by the investigator using Lugano 2014 criteria [all cohorts] | Up to 1 year after primary study treatment | |
| Best ORR (CR or PR at any time) on study as determined by the investigator using Lugano 2014 criteria [dose escalation] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: CO43805 https://forpatients.roche.com/ | Contact | 888-662-6728 | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program | Recruiting | San Francisco | California | 94143 | United States |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| IV Glofitamab | Drug | Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days) |
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| 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) |
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| 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) |
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| Obinutuzumab | Drug | Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days) |
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| Tocilizumab | Drug | Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) |
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| Up to 2 years after primary study treatment |
| Duration of response (DOR) as determined by the investigator using Lugano 2014 criteria [all cohorts] | Up to 2 years after primary study treatment |
| Progression-free survival (PFS) as determined by the investigator using Lugano 2014 criteria [dose expansion] | Up to 2 years after primary study treatment |
| Event-free survival (EFS) as determined by the investigator using Lugano 2014 criteria [dose expansion] | Up to 2 years after primary study treatment |
| Overall survival (OS) [dose expansion] | Up to 2 years after primary study treatment |
| Percentage of participants with adverse events [dose expansion] | Until 90 days after the final dose of study treatment |
| Serum concentration of subcutaneous (SC) mosunetuzumab [all cohorts] | Up to 2 years after primary study treatment |
| Serum concentration of intravenous (IV) glofitamab [all cohorts] | Up to 2 years after primary study treatment |
| Serum concentration of CC-220 and CC-99282 (CELMoDs) [all cohorts] | Up to 12 cycles of study treatment (cycle length = 21 or 28 days for Arm 1 and 21 days for Arm 2) |
| Tolerability, as assessed by the incidence of dose interruptions, dose reductions, dose intensity, and treatment discontinuation [dose expansion] | Until 90 days after the final dose of study treatment |
| University of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| The University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
| UT MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Soroka | Recruiting | Beersheba | 0084101 | Israel |
| Rambam Health Care Campus | Recruiting | Haifa | 3109600 | Israel |
| Hadassah University Hospital - Ein Kerem | Recruiting | Jerusalem | 9112001 | Israel |
| Center Hospital | Recruiting | Ramat Gan | 5262199 | Israel |
| Sourasky Medical Center | Recruiting | Tel Aviv | 6423900 | Israel |
| IRCCS Azienda Ospedaliero Universitaria di Bologna | Recruiting | Bologna | Emilia-Romagna | 40138 | Italy |
| IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori" | Recruiting | Meldola | Emilia-Romagna | 47014 | Italy |
| ASST Spedali Civili di Brescia | Recruiting | Brescia | Lombardy | 25123 | Italy |
| Irccs Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
| Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia | Recruiting | Pisa | Piedmont | 56126 | Italy |
| ICO L'Hospitalet | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital Universitario La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
| Hospital Universitari Vall d Hebron | Recruiting | Barcelona | 08035 | Spain |
| Clinica Universidad de Navarra-Madrid | Recruiting | Madrid | 28027 | Spain |
| Hospital General Universitario Gregorio Maranon | Recruiting | Madrid | 28040 | Spain |
| Hosp Universitario Salamanca | Recruiting | Salamanca | 37007 | Spain |
| NHS Greater Glasgow and Clyde | Recruiting | Glasgow | G12 0YN | United Kingdom |
| University College London Hospitals | Recruiting | London | W1T 7HA | United Kingdom |
| Nottingham University Hospitals City Campus | Recruiting | Nottingham | NG5 1PB | United Kingdom |
| Oxford University Hospitals NHS Trust - Churchill Hospital | Recruiting | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000720108 | glofitamab |
| C000624220 | iberdomide |
| C543332 | obinutuzumab |
| C502936 | tocilizumab |
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