Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05169515

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

Led by Hoffmann-La Roche · Updated on 2026-04-20

121

Participants Needed

26

Research Sites

359 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Histologically confirmed B-cell NHL expected to express CD20 antigen
  • Relapsed after or failed at least two prior systemic therapies (dose escalation phase)
  • Relapsed after or failed at least one prior systemic therapy and need systemic therapy (dose expansion phase for FL Grades 1-3a)
  • Relapsed after or failed at least one prior systemic therapy for DLBCL or transformed FL
  • For certain patients with only one prior therapy, not candidates for or refused autologous stem cell transplant or ineligible/unable to receive CAR-T therapy
  • PET-positive lymphoma confirmed by fluorodeoxyglucose-avid imaging
  • At least one measurable nodal lesion >1.5 cm or extranodal lesion >1.0 cm by CT or PET/CT
  • Availability of tumor specimen and pathology report confirming diagnosis
  • Fresh pretreatment biopsy preferred during screening
  • Adequate blood function without recent growth factors or transfusions
  • Normal laboratory test results
  • Agreement to use effective pregnancy prevention or abstain during and after treatment as specified
Not Eligible

You will not qualify if you...

  • Pregnancy, breastfeeding, or intention to become pregnant during or shortly after the study
  • Prior treatment with cereblon-modulating drugs within 4 weeks before study drugs
  • Inability to swallow pills or persistent moderate to severe diarrhea or malabsorption
  • QTc interval greater than 470 ms
  • Prior treatment with mosunetuzumab, glofitamab, CD20/CD3 bispecific antibodies, allogenic stem cell transplant, or solid organ transplant
  • Recent radiotherapy (within 2 weeks), autologous stem cell transplant (within 100 days), CAR-T therapy (within 30 days), or other recent anti-lymphoma therapies as specified
  • Live attenuated vaccine within 4 weeks before study or expected during or soon after the study
  • Current or past central nervous system lymphoma or leptomeningeal infiltration
  • History of severe allergic reactions to monoclonal antibody therapies
  • History of autoimmune diseases including myocarditis, pneumonitis, myasthenia gravis, and others
  • Major surgery or severe injury within 28 days before enrollment or planned during study
  • Unresolved toxicities from prior treatments above Grade 1 except as allowed
  • Significant other diseases that could affect study compliance or results
  • For glofitamab group, resistance to obinutuzumab monotherapy within 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 26 locations

1

UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program

San Francisco, California, United States, 94143

Actively Recruiting

2

University of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

3

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

4

The University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

5

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

Actively Recruiting

6

UT MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

7

Soroka

Beersheba, Israel, 0084101

Actively Recruiting

8

Rambam Health Care Campus

Haifa, Israel, 3109600

Actively Recruiting

9

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel, 9112001

Actively Recruiting

10

Center Hospital

Ramat Gan, Israel, 5262199

Actively Recruiting

11

Sourasky Medical Center

Tel Aviv, Israel, 6423900

Actively Recruiting

12

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, Italy, 40138

Actively Recruiting

13

IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

Meldola, Emilia-Romagna, Italy, 47014

Actively Recruiting

14

ASST Spedali Civili di Brescia

Brescia, Lombardy, Italy, 25123

Actively Recruiting

15

Irccs Ospedale San Raffaele

Milan, Lombardy, Italy, 20132

Actively Recruiting

16

Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia

Pisa, Piedmont, Italy, 56126

Actively Recruiting

17

ICO L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain, 08908

Actively Recruiting

18

Hospital Universitario La Fe

Valencia, Valencia, Spain, 46026

Actively Recruiting

19

Hospital Universitari Vall d Hebron

Barcelona, Spain, 08035

Actively Recruiting

20

Clinica Universidad de Navarra-Madrid

Madrid, Spain, 28027

Actively Recruiting

21

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28040

Actively Recruiting

22

Hosp Universitario Salamanca

Salamanca, Spain, 37007

Actively Recruiting

23

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom, G12 0YN

Actively Recruiting

24

University College London Hospitals

London, United Kingdom, W1T 7HA

Actively Recruiting

25

Nottingham University Hospitals City Campus

Nottingham, United Kingdom, NG5 1PB

Actively Recruiting

26

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford, United Kingdom, OX3 7LE

Actively Recruiting

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Research Team

R

Reference Study ID Number: CO43805 https://forpatients.roche.com/

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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