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
Condition(s) studied
Investigational drug(s) / intervention(s)
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)
Study summary
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.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program | San Francisco | California | |
| University of Colorado | Aurora | Colorado | |
| Moffitt Cancer Center | Tampa | Florida | |
| The University of Chicago | Chicago | Illinois | |
| Levine Cancer Institute | Charlotte | North Carolina | |
| UT MD Anderson Cancer Center | Houston | Texas | |
| 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 | |
| IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori" | Meldola | Emilia-Romagna | |
| Irccs Ospedale San Raffaele | Milan | Lombardy | |
| Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia | Pisa | Piedmont | |
| ICO L'Hospitalet | L'Hospitalet de Llobregat | Barcelona | |
| Hospital Universitario La Fe | Valencia | Valencia | |
| 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 |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05169515 on ClinicalTrials.gov ↗ ← All trials in Spain