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NCT04077723 · ClinicalTrials.gov registry record · 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
A Phase 1 study of Lymphoma, Non-Hodgkin, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 1
- Development phase
- 498
- Enrollment target
- 20
- Study locations
NCT04077723 is a Phase 1 study of Lymphoma, Non-Hodgkin that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 498 participants, above the 385-participant average among 56 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT04077723, a Phase 1 study of Lymphoma, Non-Hodgkin, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 498 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 498 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 385-participant average among 56 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (29% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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.
NCT04077723 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, California, Texas.
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.
What interventions are being tested in trial NCT04077723?
The interventions under investigation include: Obinutuzumab (DRUG), Glofitamab (DRUG), Tocilizumab (DRUG), Englumafusp alfa (DRUG).
Who is sponsoring clinical trial NCT04077723?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.