Evaluating Glofitamab for Pediatric and Young Adult Patients with Relapsed B-Cell Non-Hodgkin Lymphoma
Official title: 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
Run by Hoffmann-La Roche · NCT05533775 · Data updated 2026-11-12
This study is testing a new treatment called glofitamab, alone and with standard chemotherapy, to see if it helps kids and young adults with relapsed B-cell non-Hodgkin lymphoma feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 6 Months to 30 Years |
| Sex | All |
| Enrollment | 65 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | glofitamab, obinutuzumab, rituximab |
| Locations | 30 sites (Birmingham, Alabama and 29 other locations) |
| Status | Recruiting |
| Started | November 16, 2022 |
| Main results expected | November 30, 2029 |
| Study ends | November 30, 2032 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT05533775 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pediatric and young adult patients aged 6 months to 30 years with relapsed or refractory mature B-cell non-Hodgkin lymphoma.
✕Probably not a fit
Patients with non-aggressive forms of lymphoma or those who have not yet undergone standard treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and efficacy of glofitamab, both as a standalone treatment and in combination with a standard chemoimmunotherapy regimen (R-ICE), for pediatric and young adult patients suffering from relapsed or refractory mature B-cell non-Hodgkin lymphoma. Participants aged 6 months to 30 years will be enrolled based on specific eligibility criteria, including a confirmed diagnosis of aggressive mature B-NHL. The study aims to assess how well these treatment approaches work in this patient population.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for young patients with difficult-to-treat forms of B-cell non-Hodgkin lymphoma.
How similar studies have gone: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this area.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Children's Hospital of Alabama
Birmingham, Alabama, United States Recruiting -
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States Recruiting -
Kaiser Permanente Oakland Medical Center
Oakland, California, United States Recruiting -
Kaiser Permanente - Roseville
Roseville, California, United States Recruiting -
Kaiser Permanente - Santa Clara
Santa Clara, California, United States Recruiting -
Johns Hopkins University
Baltimore, Maryland, United States Recruiting
Show 24 more locations
-
Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
Childrens Mercy Hosp & Clinics
Kansas City, Missouri, United States Recruiting -
Mskcc
New York, New York, United States Recruiting -
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States Recruiting -
Queensland Children?s Hospital
South Brisbane, Queensland, Australia Recruiting -
Perth Children's Hospital
Nedlands, Western Australia, Australia Recruiting -
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil Recruiting -
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
São Paulo, São Paulo, Brazil Recruiting -
West China Second University Hospital
Chengdu, China Recruiting -
Sun Yet-sen University Cancer Center
Guangzhou, China Recruiting -
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, China Recruiting -
Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie
Prague, Czechia Recruiting -
Rigshospitalet
København Ø, Denmark Recruiting -
Hôpital Pellegrin
Bordeaux, France Recruiting -
Gustave Roussy
Villejuif, France Recruiting -
Universitaetsklinikum Muenster
Münster, Germany Recruiting -
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika
Budapest, Hungary Recruiting -
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy Recruiting -
Ospedaliera Ospedale Infantile Regina Margherita
Turin, Piedmont, Italy Recruiting -
Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu
Wroclaw, Poland Recruiting -
Seoul National University Hospital- Pediatric Site
Seoul, South Korea Recruiting -
Asan Medical Center
Seoul, South Korea Recruiting -
Hospital Universitari Vall d'Hebron
Barcelona, Spain Recruiting -
Hospital Infantil Universitario Niño Jesus
Madrid, Spain Recruiting
Study contacts
- Study coordinator: Reference Study ID Number: CO43810 https://forpatients.roche.com/ No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Hypofractionated Radiotherapy plus GM-CSF, Pomalidomide and Glofitamab for Newly Diagnosed PCNS-DLBCL
This study tests a combination therapy—hypofractionated radiotherapy with GM-CSF, pomalidomide, and glofitamab—for adults newly diagnosed with primary CNS DLBCL to see if it helps control the disease.
-
Glofit-GemOx Bridging to Liso-cel for Relapsed/Refractory Large B-Cell Lymphoma
This trial tests whether a bridging therapy with Glofit-GemOx followed by lisocabtagene maraleucel helps people with relapsed or refractory large B-cell lymphoma.
-
Glofitamab with R-CHOP for Newly Diagnosed HIV-Related Large B-Cell Lymphoma
This phase 1 study tests glofitamab plus R-CHOP chemoimmunotherapy in adults newly diagnosed with HIV-related large B-cell lymphoma to see if the regimen is safe and tolerable.
-
Pola-ZR-Glo for older patients with large B‑cell lymphoma
This trial will try combining polatuzumab vedotin, zanubrutinib, lenalidomide, and glofitamab as first-line treatment for people aged 70 and older with newly diagnosed large B‑cell lymphoma who are unfit for standard chemo or decline immunochemotherapy.
-
Glofitamab plus lenalidomide for high‑risk relapsed or refractory mantle cell lymphoma after a BTK inhibitor
This trial tests whether giving glofitamab with oral lenalidomide helps adults with high‑risk mantle cell lymphoma that has returned or not responded after prior treatments including a BTK inhibitor.
-
Glofitamab for mantle cell lymphoma after CAR-T failure
This phase 2, multicenter, single-arm study tests glofitamab in adults with mantle cell lymphoma who did not respond to or relapsed after CAR-T cell therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.