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NCT03671018 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

A Phase 1 study of B-Cell Non-Hodgkin Lymphoma, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 1
Development phase
422
Enrollment target
20
Study locations

NCT03671018: Active Phase 1 study of B-Cell Non-Hodgkin Lymphoma, sponsored by Hoffmann-La Roche.

NCT03671018 is a Phase 1 study of B-Cell Non-Hodgkin Lymphoma that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 422 participants, above the 112-participant average among 24 other B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (277% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03671018, a Phase 1 study of B-Cell Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
422 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy (3L+) for the treatment of R/R mantle cell lymphoma (MCL) and in participants with 2L+ R/R DLBCL.

Conditions Studied

B-Cell Non-Hodgkin Lymphoma

Interventions

  • DRUG Rituximab
  • DRUG Polatuzumab vedotin
  • DRUG Tocilizumab
  • DRUG Mosunetuzumab (IV)
  • DRUG Mosunetuzumab (SC)

Study Locations (20)

Pennsylvania

  • Penn State Milton S. Hershey Medical Center - Hershey
  • Fox Chase Cancer Center - Philadelphia
  • University of Pittsburgh - Hillman Cancer Center - Pittsburgh

Other

  • UZ Brussel - Brussels
  • CH Jolimont - Lobbes (Jolimont) - Haine-Saint-Paul
  • Clinique St Pierre asbl - Ottignies

Florida

  • University of Miami Miller School of Medicine - Miami
  • Moffitt Cancer Center - Tampa

Michigan

  • University of Michigan Hospital - Ann Arbor
  • Karmanos Cancer Institute - Detroit

Alabama

  • University of Alabama at Birmingham School of Medicine - Birmingham

California

  • City of Hope - Duarte

Colorado

  • University of Colorado Hospital - Anschutz Cancer Pavilion - Aurora

New York

  • New York University Langone Medical Center - New York

Trial Details

FieldValue
Enrollment Target 422 participants
Start Date 2018-09-25
Est. Completion 2025-07-20
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the registry record for NCT03671018 still lists

NCT03671018 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, above the 112-participant average among 24 other B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (277% higher).

The record links to 1 condition, with B-Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Rituximab is the first listed.

NCT03671018 names 20 study sites across 14 states, led by Pennsylvania, Other, Florida.

Frequently Asked Questions

What is clinical trial NCT03671018 about?

NCT03671018 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma". This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lym...

What is the current status of trial NCT03671018?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 422 participants. The study started on 2018-09-25. Estimated completion is 2025-07-20.

What conditions does trial NCT03671018 study?

This clinical trial studies the following conditions: B-Cell Non-Hodgkin Lymphoma.

What interventions are being tested in trial NCT03671018?

The interventions under investigation include: Rituximab (DRUG), Polatuzumab vedotin (DRUG), Tocilizumab (DRUG), Mosunetuzumab (IV) (DRUG), Mosunetuzumab (SC) (DRUG).

Who is sponsoring clinical trial NCT03671018?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03671018 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for B-Cell Non-Hodgkin 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 NCT03671018's enrollment target sits among peer trials

422 2nd of 24 the highest of 24 other B-Cell Non-Hodgkin Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other B-Cell Non-Hodgkin 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

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Related registry views

Source: ClinicalTrials.gov NCT03671018, the US trial registry maintained by the National Library of Medicine. NCT03671018 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.