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

Part of paid clinical trials in Pasadena, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04077723
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Englumafusp alfa — DRUG
    Englumafusp alfa will be administered by intravenous (IV) infusion three-weekly (Q3W) in combination with a fixed dose of obinutuzumab (Part I) and in combination with a fixed dose of glofitamab (Part II and Part III).
  • Obinutuzumab — DRUG
    A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa, then in combination with obinutuzumab Q3W (Part I). A fixed dose of obinutuzumab will be administered up to 7 days prior to the first dose of englumafusp alfa or between Day -3 and -7 (Part II and Part III).
  • Glofitamab — DRUG
    A fixed dose of glofitamab will be administered Q3W in combination with englumafusp alfa in Part II and Part III
  • Tocilizumab — DRUG
    Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).

Study Details

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).

Key Dates

Start date
Aug 13, 2019
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
498 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part I
    Combination Dose-Escalation: Mixed r/r NHL participants will receive a fixed dose of obinutuzumab up to seven days prior to first administration of englumafusp alfa. Englumafusp alfa will be administered by intravenous (IV) infusion in combination with obinutuzumab in a three-weekly schedule (Q3W).
  • Experimental: Part II
    Combination Dose-Escalation: Mixed r/r participants and participants with mixed r/r mantle cell lymphoma (MCL) and Richters transformation will receive a fixed dose of obinutuzumab seven days prior to first administration of englumafusp alfa. Englumafusp alfa will be administered by IV infusion in combination with glofitamab in a three-weekly schedule (Q3W).
  • Experimental: Part III
    Dose-Expansion Stage: Participants with r/r diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), and DLBCL arising from FL (transformed FL) will receive englumafusp alfa administered by IV infusion in combination with glofitamab in a three-weekly schedule (Q3W).

Primary Outcome Measure

Nature and frequency of dose-limiting toxicities (DLTs) [ Time Frame: 28 days in Part I and Part II ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterPasadenaCalifornia91105-
University of California San FranciscoSan FranciscoCalifornia94158-
Washington University School of MedicineSt LouisMissouri63110-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009-

Find similar trials in Pasadena, CA

By research site
City of Hope Medical Center· Pasadena, CAUniversity of California San Francisco· San Francisco, CAWashington University School of Medicine· St Louis, MOThe University of Texas MD Anderson Cancer Center· Houston, TX

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