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Glofitamab for Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

This study is looking at a new immunotherapy drug called glofitamab, either by itself or combined with standard chemotherapy (obinutuzumab, rituximab, ifosfamide, and carboplatin). It's for children and young adults aged 6 months to 30 years who have mature B-cell non-Hodgkin lymphoma that has come back or hasn't responded to previous treatments. The main goals are to see how safe the treatments are and how well they work at getting rid of the cancer. Doctors will be looking for a complete response, meaning the cancer is no longer detectable. The study is currently recruiting about 65 participants.

Study design
This interventional study is designed to evaluate glofitamab as a monotherapy and in combination with chemoimmunotherapy in approximately 65 participants. The phase of the study is not specified.
What's involved
Participants will receive intravenous (IV) treatments over cycles lasting 21 days. The specific schedule of treatments varies by arm, with some treatments given on certain days of each cycle.
Compensation
Not stated in the trial record.
Follow-up
Participants in Arm A will be monitored for adverse events for approximately 3 years. Serum concentration of glofitamab will be measured for up to 3 treatment cycles.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05533775

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

Recruiting
PHASE1Ages 6–30InterventionalTreatment
Hoffmann-La Roche
~65 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:ObinutuzumabGlofitamabRituximabIfosfamideCarboplatinEtoposide

At a glance

Recruiting sites
30 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Achievement of a complete response (CR) as determined by the investigator according to the International Pediatric NHL Response Criteria for pediatric participants and Lugano Classification for young adult participants (Arm A)
Measured over Up to 3 treatment cycles (cycle length = 21 days)
+3 more outcomes measured

Conditions

Mature B-Cell Non-Hodgkin Lymphoma

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Where you'd take part

This study runs at 30 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Asan Medical Center

    Seoul, South Koreano site contact published

    Recruiting

  • Children's Hospital of Alabama

    Birmingham, Alabamano site contact published

    Recruiting

  • Childrens Mercy Hosp & Clinics

    Kansas City, Missourino site contact published

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohiono site contact published

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsno site contact published

    Recruiting

  • Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie

    Prague, Czechiano site contact published

    Recruiting

  • Graacc-Grupo de Apoio ao adolescente e a crianca com cancer

    São Paulo, São Paulo, Brazilno site contact published

    Recruiting

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-LaRoche

Who to contact

Reference Study ID Number: CO43810 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728
Email the study team

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Eligibility criteria

Inclusion

Age 6 months to \< 18 years at the time of signing Informed Consent for Cohort A Part 1 and Cohort B of the study, and age 6 months to \< 30 years old at the time of signing Informed Consent for Cohort A 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

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

What this trial measures

  • Achievement of a complete response (CR) as determined by the investigator according to the International Pediatric NHL Response Criteria for pediatric participants and Lugano Classification for young adult participants (Arm A)Up to 3 treatment cycles (cycle length = 21 days)
  • Percentage of participants with adverse events (AEs) (Arm A)Approximately 3 years
  • Serum concentration of glofitamab in combination with R-ICE chemoimmunotherapy (Arm A)Up to 3 treatment cycles (cycle length = 21 days)
  • Serum concentration of glofitamab monotherapy (Arm B)Up to 12 treatment cycles (Arm B) (cycle length = 21 days)