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

NCT05364424 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: GO43693
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR), defined as the proportion of participants that achieves a CR or PR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria

  Up to 2.5 years

Secondary Outcomes (12)

• Event-free survival (EFS) after enrollment

  From enrollment to the first occurrence of disease progression, initiation of new anti-lymphoma therapy (not including planned ASCT or CAR-T therapy), or death from any cause (whichever occurs first) (up to 2.5 years)

• Progression-free survival (PFS) after enrollment

  From enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first) as determined by the investigator according to Lugano criteria (up to 2.5 years)

• Mobilization-adjusted response rate (MARR)

  Up to 2.5 years

• Overall survival (OS) after enrollment

  From enrollment to death from any cause (up to 2.5 years)

• CR rate after enrollment, defined as the proportion of participants that achieves a CR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria

  Up to 2.5 years

Study Arms (1)

R/R DLBCL

EXPERIMENTAL

Participants will receive up to 3 21-day cycles of glofitamab, rituximab, ifosfamide, carboplatin, and etoposide (glofit-R-ICE).

Drug: Glofitamab; Drug: Obinutuzumab; Drug: Tocilizumab; Drug: Rituximab; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide

Interventions

Glofitamab DRUG

Participants will receive intravenous (IV) glofitamab for up to 3 cycles.

R/R DLBCL

Obinutuzumab DRUG

Participants will receive IV obinutuzumab on Cycle 1 Day 1.

R/R DLBCL

Tocilizumab DRUG

Participants will receive IV tocilizumab as necessary to manage cytokine release syndrome (CRS) events.

R/R DLBCL

Rituximab DRUG

Participants will receive up to 2 doses of IV rituximab.

R/R DLBCL

Ifosfamide DRUG

Participants will receive IV ifosfamide for up to 3 cycles.

R/R DLBCL

Carboplatin DRUG

Participants will receive IV carboplatin for up to 3 cycles.

R/R DLBCL

Etoposide DRUG

Participants will receive IV etoposide for up to 3 cycles.

R/R DLBCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-T therapy

You may not qualify if:

• 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 CD20 and CD3
• Peripheral neuropathy assessed to be Grade \> 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
• Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
• Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
• Primary or secondary CNS lymphoma at the time of enrollment or history of CNS lymphoma
• Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
• Known history of progressive multifocal leukoencephalopathy
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (9)

Chao Family Comprehensive Cancer Center UCI

Orange, California, 92868, United States

Location

Memorial Cancer Institute at Memorial West

Pembroke Pines, Florida, 33028, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

glofitamab; obinutuzumab; tocilizumab; Rituximab; Ifosfamide; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: November 4, 2022
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)