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2022-502616-37-00Active, not recruitingPhase 1/2

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa (RO7227166, a CD19 targeted 4-1BB ligand) in Combination with Obinutuzumab and in Combination with Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

An Open-Label, Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa (RO7227166, a CD19 Targeted 4-1BB Ligand) in Combination with Obinutuzumab and in Combination with Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Oct 2026

Next steps

Brief summary (registry, in English)

Part I/II (Dose-Escalation) 1. 1. To determine the maximum tolerated dose and/ or recommended Phase 2 dose (RP2D) of englumafusp alfa in combination with obinutuzumab and in combination with glofitamab following obinutuzumab pre-treatment (GpT) or double GpT (DGpT) in participants with r/r B-cell NHL (Part I and IIA) and in participants with r/r MCL and Richter’s transformation (Part IIB) 2. To evaluate the safety and tolerability of englumafusp alfa in combination with obinutuzumab and in combination with glofitamab following GpT or DGpT in participants with r/r B-cell NHL (Part I and IIA) and in participants with r/r MCL and Richter’s transformation (Part IIB) Part III (Dose-Expansion) 3. A1: To compare anti-tumor activity of englumafusp alfa at selected doses (in combination with glofitamab and glofitamab monotherapy) in participants with r/r large B-cell lymphoma (LBCL) 4. A2 and B: To demonstrate anti- tumor activity of englumafusp alfa in combination with glofitamab in r/r follicular lymphoma (FL) and MCL

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
194 (estimated)
First submitted
11 Jan 2024
Start date
30 Jul 2019
Lead sponsor
F. Hoffmann-La Roche AG
EU CT number
2022-502616-37-00
EudraCT number
2019-000416-28

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 194
  • 18 sites in 5 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

  • Participants with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to obinutuzumab infusion or by clinical judgment in the absence of a positive blood culture
  • Participants with known active infection, or reactivation of a latent infection, whether bacterial, viral fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics
  • Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines or monoclonal antibodies within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion on D-7
  • History of treatment-emergent immune-related AEs associated with prior immunotherapeutic agents and auto-immune disease - Grade >= 3 AEs with the exception of Grade 3 endocrinopathy managed with replacement therapy and Grade 3 CRS which has fully resolved - Grade 1-2 AEs that did not resolve to baseline after treatment discontinuation
  • Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational or approved anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to obinutuzumab infusion

Lab values

  • Circulating lymphoma cells, defined by out of range (high) absolute lymphocyte count or the presence of abnormal cells in the peripheral blood signifying circulating lymphoma cells

Who the study is looking for

  • Willing and able to comply with protocol-mandated hospitalization per protocol. Participants must also be willing to comply with all study-related procedures
  • A history or status of: - a histologically-confirmed hematological malignancy that is expected to express CD19 and CD20; - certain B-cell malignancies with relapse after or failure to respond to at least one prior treatment regimen for Part I and II - certain B-cell malignancies with relapse after or failure to respond to only one prior systemic treatment regimen for Part 3 - no available treatment options that are expected to prolong survival
  • Must have at least one measureable target lesion (>= 1.5 cm) in its largest dimension by computed tomography scan
  • Able and willing to provide a fresh biopsy from a safely accessible site, per Investigator’s determination, providing the participant has more than one measurable target lesion. However, in the absence of fresh biopsy, provide the most recent archival tumor tissue samples that are preferably not older than 6 months and preferably not confounded by major events. For archival biopsies formalin-fixed, paraffin-embedded blocks are preferred, but if not available, unstained slides are acceptable
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Life expectancy of >= 12 weeks

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (18)

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

SiteCityCountrySite status
Universitair Ziekenhuis GentGentBelgiumActive, not recruiting
Aarhus UniversitetshospitalAarhus NDenmarkActive, not recruiting
RigshospitaletCopenhagen OeDenmarkActive, not recruiting
Odense University HospitalOdense CDenmarkActive, not recruiting
Hospital Universitari Vall d'HebronBarcelonaSpainActive, not recruiting
Institut Catala D'oncologiaL'Hospitalet de LlobregatSpainActive, not recruiting
Clinica Universidad de NavarraMadridSpainActive, not recruiting
Hospital Universitario 12 de OctubreMadridSpainActive, not recruiting
Hospital Universitario Virgen de la VictoriaMálagaSpainActive, not recruiting
Clínica Universidad de navarraPamplonaSpainActive, 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
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamoItalyActive, not recruiting
Istituto Europeo di Oncologia s.r.lMilanItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione PascaleNaplesItalyActive, not recruiting
Humanitas Research HospitalRozzanoItalyActive, not recruiting

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