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RECRUITING
NCT05169515
PHASE1

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

121

Start Date

2022-10-26

Completion Date

2029-09-15

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

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)

DRUG

IV Glofitamab

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

DRUG

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)

DRUG

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)

DRUG

Obinutuzumab

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

DRUG

Tocilizumab

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