A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma (iMATRIX GLO)

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Status and phase

Phase 2
Phase 1


Mature B-Cell Non-Hodgkin Lymphoma


Drug: Ifosfamide
Drug: Rituximab
Drug: Etoposide
Drug: Obinutuzumab
Drug: Tocilizumab
Drug: Carboplatin
Drug: Glofitamab

Study type


Funder types




Details and patient eligibility


The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL).


65 estimated patients




6 months to 30 years old


No Healthy Volunteers

Inclusion criteria

  • Age 6 months to < 18 years at the time of signing Informed Consent for Part 1 and Cohort B of the study, and age 6 months to ≤ 30 years old at the time of signing Informed Consent for Part 2 of the study
  • Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-NHL that expresses CD20 (reconfirmed by IHC or flow cytometry if IHC is not possible), including BL, BAL (mature B-cell leukemia FAB L3), DLBCL, and PMBCL, at the time of first R/R disease for Cohort A and second or greater R/R disease for Cohort B
  • Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B
  • Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension; or percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates
  • Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales: Participants < 16 years old: Lansky Performance Status ≥ 50%; Participants ≥ 16 years old: Karnofsky Performance Status ≥ 50%
  • Adequate bone marrow, liver, and renal function
  • Negative test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV)
  • Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
  • Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment
  • Participants and/or caregivers who are willing and able to complete clinical outcome assessments throughout the study using either paper or interviewer methods

Exclusion criteria

  • Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNS lymphoma
  • Receipt of glofitamab prior to study enrollment
  • Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade ≤ 1 (exceptions: alopecia, Grade 2 peripheral neuropathy)
  • Grade ≥ 3 adverse events, with the exception of Grade 3 endocrinopathy managed with replacement therapy
  • Participants with active infections which are not resolved prior to Day 1 of Cycle 1
  • Prior solid organ transplantation
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH), or chronic active Epstein-Barr viral infection (CAEBV)
  • Active autoimmune disease requiring treatment
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products, except if the participant was able to safely receive it after initial administration (consider consultation with Medical Monitor)
  • History of confirmed progressive multifocal leukoencephalopathy
  • Current or past history of uncontrolled non-malignant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
  • Major surgery or significant traumatic injury < 28 days prior to the obinutuzumab pretreatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
  • Administration of a live, attenuated vaccine within 4 weeks before the start of study treatment (obinutuzumab pretreatment) or at any time during the study treatment period and within 12 months after end of study treatment
  • Participants with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

65 participants in 2 patient groups

Arm A
Experimental group
Participants will receive glofitamab + R-ICE chemoimmunotherapy for up to 3 cycles (cycle length = 21 days).
Drug: Carboplatin
Drug: Glofitamab
Drug: Tocilizumab
Drug: Etoposide
Drug: Obinutuzumab
Drug: Rituximab
Drug: Ifosfamide
Arm B
Experimental group
Participants will receive glofitamab monotherapy for up to 12 cycles (cycle length = 21 days).
Drug: Glofitamab
Drug: Tocilizumab
Drug: Obinutuzumab

Trial contacts and locations



Central trial contact

Reference Study ID Number: CO43810

Data sourced from

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