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ACTIVE NOT RECRUITING Phase 1

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

NCT04077723 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of englumafusp alfa (RO7227166) in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). Englumafusp alfa will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered up to seven days prior to the first administration of englumafusp alfa and seven days prior to the first administration of glofitamab. This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).

Conditions Studied

Interventions

  • DRUG Obinutuzumab
  • DRUG Glofitamab
  • DRUG Tocilizumab
  • DRUG Englumafusp alfa

Study Locations (20)

Other

  • UZ Gent — Ghent
  • Beijing Cancer Hospital — Beijing
  • Shandong Cancer Hospital — Jinan
  • Fudan University Shanghai Cancer Center — Shanghai
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • Aarhus Universitetshospital Skejby — Aarhus N

California

  • City of Hope Medical Center — Pasadena
  • University of California San Francisco — San Francisco

Texas

  • South Austin Medical Center — Austin
  • The University of Texas MD Anderson Cancer Center — Houston

Victoria

  • Peter Maccallum Cancer Centre — Melbourne
  • The Alfred Hospital — Melbourne

Colorado

  • Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center — Denver

Massachusetts

  • Beth Israel Medical Center — Boston

Missouri

  • Washington University School of Medicine — St Louis

New York

  • MSKCC — New York

Trial Details

FieldValue
Enrollment Target 498 participants
Start Date 2019-08-13
Est. Completion 2027-03-31
Phase Phase 1

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04077723

The ClinicalTrials.gov registry entry for NCT04077723 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 498 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Lymphoma, Non-Hodgkin appearing as the primary indexed condition, and to 4 interventions — of which Obinutuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04077723 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04077723 about?

NCT04077723 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma". This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of englumafusp alfa (RO7227166) in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). Englumafusp alfa will be administered by intravenous (IV) infusion in combina...

What is the current status of trial NCT04077723?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 498 participants. The study started on 2019-08-13. Estimated completion is 2027-03-31.

What conditions does trial NCT04077723 study?

This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04077723?

The interventions under investigation include: Obinutuzumab (DRUG), Glofitamab (DRUG), Tocilizumab (DRUG), Englumafusp alfa (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04077723?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04077723 being conducted?

This trial has 20 study locations across California, Colorado, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial