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 now · Phase 1/Phase 2

Conditions studied: Mature B-Cell Non-Hodgkin Lymphoma

In brief

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).

Key facts

Study ID

NCT05533775

Run by

Hoffmann-La Roche

People needed

65

Starts

2022-11-16

Expected to finish

2032-11-30

Last updated by the study team

2026-08-05

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States (enrolling)
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States (enrolling)
• Kaiser Permanente Oakland Medical Center — Oakland, California, United States (enrolling)
• Kaiser Permanente - Roseville — Roseville, California, United States (enrolling)
• Kaiser Permanente - Santa Clara — Santa Clara, California, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Childrens Mercy Hosp & Clinics — Kansas City, Missouri, United States (enrolling)
• MSKCC — New York, New York, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Queensland Children?s Hospital — South Brisbane, Queensland, Australia (enrolling)
• Perth Children's Hospital — Nedlands, Western Australia, Australia (enrolling)
• Hospital Erasto Gaertner — Curitiba, Paraná, Brazil (enrolling)
• Graacc-Grupo de Apoio ao adolescente e a crianca com cancer — São Paulo, São Paulo, Brazil (enrolling)
• West China Second University Hospital — Chengdu, China (enrolling)
• Sun Yet-sen University Cancer Center — Guangzhou, China (enrolling)
• Guangxi Cancer Hospital of Guangxi Medical University — Nanning, China (enrolling)
• Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie — Prague, Czechia (enrolling)
• Rigshospitalet — København Ø, Denmark (enrolling)
• Hôpital Pellegrin — Bordeaux, France (enrolling)
• Gustave Roussy — Villejuif, France (enrolling)
• Universitaetsklinikum Muenster — Münster, Germany (enrolling)
• Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika — Budapest, Hungary (enrolling)
• IRCCS Ospedale Pediatrico Bambino Gesù — Rome, Lazio, Italy (enrolling)
• Ospedaliera Ospedale Infantile Regina Margherita — Turin, Piedmont, Italy (enrolling)

Full record on ClinicalTrials.gov

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