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2023-505625-14-00Active, not recruitingPhase 1/2

A Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination with Obinutuzumab, Administered After a Fixed, Single Dose Pre-treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

A Multicenter, Open-Label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination with Obinutuzumab Administered After a Fixed, Single Dose Pre-Treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Nov 2026

Next steps

Brief summary (registry, in English)

To determine:  the maximal tolerated dose or optimal biologic dose and dose-limiting toxicity of glofitamab as single agent and in combination with obinutuzumab following Gpt in patients with r/r NHL  a recommended dose and schedule of glofitamab as single agent and in combination with obinutuzumab following Gpt To evaluate:  The safety, tolerability, and pharmacokinetic (PK) of glofitamab as single agent and in combination with obinutuzumab following obinutuzumab pretreatment (Gpt) in patients with r/r (CD)20 + B-cell NHL  The efficacy of glofitamab as single agent following Gpt in patients in patients with Diffuse large B-cell lymphoma, and in patients with r/r Follicular lymphoma (FL) measured by Independent Review Committee (IRC)-assessed complete response rate (CRR) according to Lugano 2014 Classification  To evaluate the efficacy of glofitamab as single agent following Gpt and/or dGpt in R/R MCL patients by IRC-assessed CRR according to Lugano Classification

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
459 (estimated)
First submitted
9 Jul 2024
Start date
31 Jan 2017
Lead sponsor
F. Hoffmann-La Roche AG
EU CT number
2023-505625-14-00
EudraCT number
2016-001185-28

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 459
  • 22 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to Gpt infusion or by clinical judgment in the absence of a positive blood culture
  • Patients with known active infection, or reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing  A severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) or antigen test within 7 days prior to enrollment is recommended

Other illness

  • Patients with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)

Other

  • Inability to comply with protocol mandated hospitalization and restrictions
  • Patients with chronic lymphocytic leukemia (CLL), Burkitt lymphoma and lymphoplasmacytic lymphoma
  • Pregnant, breast-feeding or intending to become pregnant during the study

Who the study is looking for

  • Patient willing and able to comply with protocol-mandated hospitalizations upon administration of glofitamab and also all study-related procedures, in Part III, this includes completion of Patient-reported outcome
  • For Parts I and II:Grades 1-3b FL; Marginal zone lymphoma; Mantle cell lymphoma; DLBCL; Primary mediastinal B-cell lymphoma; Richter’s transformation; and transformed FL (trFL) For Part III expansion cohorts: DLBCL cohort (r/r DLBCL, not otherwise specified [NOS]/high-grade B-cell lymphoma [HGBCL],PMBCL and trFL). Patients must have relapsed after or failed to respond to at least two prior systemic treatment regimens (including at least one prior regimen containing anthracycline, and at least one containing an anti CD20-directed therapy). cohort: R/R FL cohort: Grades 1-3a FL patients must have relapsed after or failed to respond to at least two prior lines of systemic therapy and must have received prior treatment with rituximab and alkylating agents
  • For Part III expansion cohorts: Life expectancy (in the opinion of the Investigator) of >= 12 weeks
  • 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
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Adequate liver, hematological, and renal function

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (22)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis GentGentBelgiumActive, not recruiting
Cliniques Universitaires Saint-LucSint-Lambrechts-WoluweBelgiumActive, not recruiting
Vseobecna fakultni nemocnice v PrazePragueCzechiaActive, not recruiting
RigshospitaletCopenhagen OeDenmarkActive, not recruiting
Hospital Germans Trias i PujolBadalonaSpainActive, not recruiting
Hospital Universitari Vall d'HebronBarcelonaSpainActive, not recruiting
Hospital del MarBarcelonaSpainActive, not recruiting
Institut Catala D'oncologiaL'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario 12 de OctubreMadridSpainActive, not recruiting
Hospital Universitario Marqués de ValdecillaSantanderSpainActive, not recruiting
HUS-YhtymaeHelsinkiFinlandActive, not recruiting
Assistance Publique Hopitaux De ParisCreteilFranceActive, not recruiting
Centre Hospitalier Universitaire de LilleLilleFranceActive, not recruiting
Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5FranceActive, not recruiting
Hospices Civils de LyonPierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de RennesRennesFranceActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei TumoriMilanItalyActive, not recruiting
Azienda Unità Sanitaria Locale della RomagnaRavennaItalyActive, not recruiting
Humanitas Mirasole S.p.A.RozzanoItalyActive, not recruiting
Uniwersyteckie Centrum KliniczneGdanskPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny w PoznaniuPoznanPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclawPolandActive, not recruiting

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