RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT05533775

Registry updated: 2026-10-06

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Description

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).

Interventions

Obinutuzumab (Drug)
Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)
Glofitamab (Drug)
Arm A: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of Cycles 2 and 3 Arm B: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of each cycle thereafter (Cycle length = 21 days)
Rituximab (Drug)
Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Ifosfamide (Drug)
Participants will receive IV ifosfamide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Carboplatin (Drug)
Participants will receive IV carboplatin on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Etoposide (Drug)
Participants will receive IV etoposide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Tocilizumab (Drug)
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events

Eligibility criteria

Inclusion Criteria: * 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 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

Conditions

Mature B-Cell Non-Hodgkin Lymphoma

Locations

Children's Hospital of Alabama — Birmingham, Alabama, United States
UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
Kaiser Permanente Oakland Medical Center — Oakland, California, United States
Kaiser Permanente - Roseville — Roseville, California, United States
Kaiser Permanente - Santa Clara — Santa Clara, California, United States
Johns Hopkins University — Baltimore, Maryland, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Childrens Mercy Hosp & Clinics — Kansas City, Missouri, United States
MSKCC — New York, New York, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Queensland Children?s Hospital — South Brisbane, Queensland, Australia
Perth Children's Hospital — Nedlands, Western Australia, Australia
Hospital Erasto Gaertner — Curitiba, Paraná, Brazil
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer — São Paulo, São Paulo, Brazil
West China Second University Hospital — Chengdu, China
Sun Yet-sen University Cancer Center — Guangzhou, China
Guangxi Cancer Hospital of Guangxi Medical University — Nanning, China
Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie — Prague, Czechia
Rigshospitalet — København Ø, Denmark
Hôpital Pellegrin — Bordeaux, France
Gustave Roussy — Villejuif, France
Universitaetsklinikum Muenster — Münster, Germany
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika — Budapest, Hungary
IRCCS Ospedale Pediatrico Bambino Gesù — Rome, Lazio, Italy
Ospedaliera Ospedale Infantile Regina Margherita — Turin, Piedmont, Italy
Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu — Wroclaw, Poland
Seoul National University Hospital- Pediatric Site — Seoul, South Korea
Asan Medical Center — Seoul, South Korea
Hospital Universitari Vall d'Hebron — Barcelona, Spain
Hospital Infantil Universitario Niño Jesus — Madrid, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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