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
- Diseases
- Childhood cancers
- 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
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Perth Children's Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Queensland Children's Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| Hospital Erasto Gaertner Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| West China Second University Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Sun Yet-Sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangxi Cancer Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Universitaetsklinikum Muenster Coordinator of this site? Confirm its status | Münster | Germany | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | København Ø | Denmark | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hopital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| IRCCS Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Ospedaliera Ospedale Infantile Regina Margherita Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital- Pediatric Site Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Children's Hospital of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Childrens Mercy Hosp & Clinics Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| MSKCC Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Kaiser Permanente Oakland Medical Center Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| UCSF Benioff Children's Hospital Oakland Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| Kaiser Permanente-Roseville Coordinator of this site? Confirm its status | Roseville | United States | Recruiting |
| Kaiser Permanente Santa Clara Coordinator of this site? Confirm its status | Santa Clara | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.