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NCT05533775RecruitingPhase 1/2

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

A Phase I/II, Open-Label, Single-Arm, Two-Part Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination With Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
65 (estimated)
First submitted
6 Sept 2022
Start date
16 Nov 2022
Primary completion date
30 Nov 2029
Lead sponsor
Hoffmann-La Roche
NCT number
NCT05533775

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 65
  • From 16 Nov 2022 to the primary completion date, 30 Nov 2029
  • 30 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNS lymphoma
  • 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

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 6 months to 30 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Perth Children's Hospital
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NedlandsAustraliaRecruiting
Queensland Children's Hospital
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South BrisbaneAustraliaRecruiting
Hospital Erasto Gaertner
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CuritibaBrazilRecruiting
GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer
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São PauloBrazilRecruiting
West China Second University Hospital
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ChengduChinaRecruiting
Sun Yet-Sen University Cancer Center
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GuangzhouChinaRecruiting
Guangxi Cancer Hospital of Guangxi Medical University
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NanningChinaRecruiting
Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie
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PragueCzechiaRecruiting
Universitaetsklinikum Muenster
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MünsterGermanyRecruiting
Rigshospitalet
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København ØDenmarkRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Infantil Universitario Nino Jesus
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MadridSpainRecruiting
Hopital Pellegrin
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BordeauxFranceRecruiting
Gustave Roussy
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VillejuifFranceRecruiting
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika
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BudapestHungaryRecruiting
IRCCS Ospedale Pediatrico Bambino Gesù
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RomeItalyRecruiting
Ospedaliera Ospedale Infantile Regina Margherita
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TurinItalyRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Seoul National University Hospital- Pediatric Site
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SeoulSouth KoreaRecruiting
Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu
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WroclawPolandRecruiting
Johns Hopkins University
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BaltimoreUnited StatesRecruiting
Children's Hospital of Alabama
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BirminghamUnited StatesRecruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesRecruiting
Childrens Mercy Hosp & Clinics
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Kansas CityUnited StatesRecruiting
MSKCC
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New YorkUnited StatesRecruiting
Kaiser Permanente Oakland Medical Center
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OaklandUnited StatesRecruiting
UCSF Benioff Children's Hospital Oakland
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OaklandUnited StatesRecruiting
Kaiser Permanente-Roseville
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RosevilleUnited StatesRecruiting
Kaiser Permanente Santa Clara
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Santa ClaraUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.