RecruitingPhase 1NCT05169515

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

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Patients With B-Cell Non-Hodgkin Lymphoma

Sponsor

Hoffmann-La Roche

Enrollment

121 participants

Start Date

Oct 26, 2022

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing combinations of mosunetuzumab or glofitamab (drugs that help the immune system fight cancer) with CC-220 and/or CC-99282 (drugs that disrupt cancer cell growth) in people with B-cell non-Hodgkin lymphoma (NHL) — a group of blood cancers — that has returned or not responded to prior treatments. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) / transformed FL, confirmed by biopsy - Your lymphoma tests positive for the CD20 protein - You have relapsed after or did not respond to at least one (FL) or two (dose escalation phase) prior lines of treatment - You have at least one measurable lesion on imaging **You may NOT be eligible if...** - Your lymphoma cannot be seen on PET scan - You are not a candidate for and have not been offered stem cell transplant or CAR-T therapy (if applicable) - You have serious ongoing infections or organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSC 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)

DRUGIV Glofitamab

Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days)

DRUGIberdomide

Arm 1: Participants will receive oral CC-220 from Day 1-21 of Cycle 2-12 (cycle length = 28 days for Cycles 2-12)

DRUGGolcadomide

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)

DRUGObinutuzumab

Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)

DRUGTocilizumab

Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)

Locations(26)

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

View Full Details on ClinicalTrials.gov

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NCT05169515

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