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A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
NCT03075696 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-into-human (EIH) study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Glofitamab
- DRUG Tocilizumab
Study Locations (20)
Other
- Cliniques Universitaires St-Luc — Brussels
- UZ Gent — Ghent
- Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK — Prague
- Rigshospitalet — København Ø
- Helsinki University Central Hospital — Helsinki
- Hopital Henri Mondor — Créteil
- Hopital Claude Huriez — Lille
- CHU Saint Eloi — Montpellier
- Ch Lyon Sud — Pierre-Bénite
New York
- Mount Sinai Medical Center — New York
- MSKCC — New York
Illinois
- Ingalls Memorial Hospital — Harvey
Michigan
- University of Michigan — Ann Arbor
Missouri
- Washington University — St Louis
Pennsylvania
- Allegheny Health Network (Pittsburg PA) — Pittsburgh
Utah
- Hunstman Cancer Institute — Salt Lake City
Washington
- Swedish Cancer Inst. — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 940 participants |
| Start Date | 2017-02-21 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03075696
The ClinicalTrials.gov registry entry for NCT03075696 describes a study currently listed as 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 940 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 Non-Hodgkin's Lymphoma appearing as the primary indexed condition, and to 3 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: NCT03075696 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, New York, Illinois. 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 NCT03075696 about?
NCT03075696 is a clinical study titled "A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma". This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, fol...
What is the current status of trial NCT03075696?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 940 participants. The study started on 2017-02-21. Estimated completion is 2029-12-31.
What conditions does trial NCT03075696 study?
This clinical trial studies the following conditions: Non-Hodgkin's Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03075696?
The interventions under investigation include: Obinutuzumab (DRUG), Glofitamab (DRUG), Tocilizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03075696?
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 NCT03075696 being conducted?
This trial has 20 study locations across Illinois, Michigan, Missouri, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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