A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

Last updated: June 12, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoma, B-cell

Lymphoma

Treatment

Etoposide

Carboplatin

Obinutuzumab

Clinical Study ID

NCT05364424
GO43693
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Life expectancy ≥ 12 weeks

  • Histologically confirmed B-cell lymphoma

  • One line of prior systemic therapy including an anti-CD20 monoclonal antibody (i.e.rituximab) and an anthracycline

  • Relapsed or refractory disease after first-line chemoimmunotherapy

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

  • Participant must be a candidate for high-dose chemotherapy followed by ASCT or CAR-Ttherapy

Exclusion

Exclusion Criteria:

  • Treatment with more than one prior line of therapy for DLBCL

  • Primary mediastinal B-cell lymphoma

  • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20and CD3

  • Peripheral neuropathy assessed to be Grade > 1 according to National CancerInstitute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 atenrollment

  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy,or any investigational agent for the purposes of treating cancer within 2 weeksprior to first study treatment

  • Treatment with monoclonal antibodies for the purposes of treating cancer within 4weeks prior to first study treatment

  • Primary or secondary CNS lymphoma at the time of enrollment or history of CNSlymphoma

  • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, orneurodegenerative disease

  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)

  • Known history of progressive multifocal leukoencephalopathy

  • Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 orbetter (with the exception of alopecia and anorexia, or as otherwise permitted byinclusion criteria)

  • Prior solid organ transplantation

  • Prior allogeneic stem cell transplant

  • Prior ASCT for lymphoma

  • Prior autologous stem cell transplant for any indication other than lymphoma, within 5 years from the start of study treatment

  • Active autoimmune disease requiring treatment

  • Prior treatment with systemic immunosuppressive medications (including, but notlimited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, andanti-tumor necrosis factor agents), within 4 weeks prior to first dose of studytreatment

  • Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Participants whoreceived corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent mustbe documented to be on a stable dose of at least 4 weeks' duration prior to Cycle 1Day 1. Participants may have received a brief (≤ 7 days) course of systemic steroids (≤ 100 mg prednisone equivalent per day) prior to initiation of study therapy forcontrol of lymphoma-related symptoms

  • Recent major surgery (within 4 weeks before the first study treatment) other thanfor diagnosis

  • Clinically significant history of cirrhotic liver disease

Study Design

Total Participants: 43
Treatment Group(s): 7
Primary Treatment: Etoposide
Phase: 1
Study Start date:
November 04, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Chao Family Comprehensive Cancer Center UCI

    Orange, California 92868
    United States

    Site Not Available

  • Memorial Cancer Institute at Memorial West

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Memorial Cancer Institute at Memorial West

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Tulane Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Tulane Medical Center; Investigational/Research Pharmacy

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • UMASS Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • New York University Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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