Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03075696 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Non-Hodgkin's Lymphoma, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 940
- Enrollment target
- 20
- Study locations
NCT03075696: Recruiting Phase 1 study of Non-Hodgkin's Lymphoma, sponsored by Hoffmann-La Roche.
NCT03075696 is a Phase 1 study of Non-Hodgkin's Lymphoma that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 940 participants, above the 207-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (354% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03075696, a Phase 1 study of Non-Hodgkin's Lymphoma, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 940 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT03075696 shows while recruiting
NCT03075696 is an interventional study that assigns participants to a tested intervention. The registered 940 participants enrollment target is mid-sized for trials with a published cap, above the 207-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (354% higher).
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.
NCT03075696 names 20 study sites across 11 states, led by Other, New York, Illinois.
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.
What interventions are being tested in trial NCT03075696?
The interventions under investigation include: Obinutuzumab (DRUG), Glofitamab (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT03075696?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Non-Hodgkin's Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03075696's enrollment target sits among peer trials
940 5th of 63 higher than 59 of 63 other Non-Hodgkin's Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin's Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
RECRUITING · Phase 1
-
Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE
RECRUITING · Phase 1
-
Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma
RECRUITING · Phase 1
-
T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
RECRUITING · Phase 1
-
Activated T Lymphocytes Expressing CARs, Relapsed CD19+ Malignancies Post-Allo HSCT(CARPASCIO)
ACTIVE NOT RECRUITING · Phase 1
-
High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06855277 · 940 participants · Phase 3
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
- NCT06808334 · 942 participants
CLAiR Pivotal Study
- NCT07190209 · 942 participants · Phase 3
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
- NCT07190222 · 942 participants · Phase 3
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI