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New combo therapy shows promise for Tough-to-Treat lymphoma

NCT ID NCT05364424

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new drug, glofitamab, combined with standard chemotherapy (R-ICE) in 43 people with diffuse large B-cell lymphoma that returned or didn't respond to first treatment. Participants were eligible for a stem cell transplant or CAR-T therapy. The goal was to see if the combination could shrink tumors and how safe it was.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

43 people

The number who actually took part.

Started

Nov 2022

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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-T therapy 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 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 * Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia, or as otherwise permitted by inclusion 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 not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 4 weeks prior to first dose of study treatment * Ongoing corticosteroid use \> 30 mg/day of prednisone or equivalent. Participants who received corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to Cycle 1 Day 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 for control of lymphoma-related symptoms * Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis * Clinically significant history of cirrhotic liver disease

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chao Family Comprehensive Cancer Center UCI

    Orange, California, 92868, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Cancer Institute at Memorial West

    Pembroke Pines, Florida, 33028, United States

  • New York University Langone Medical Center

    New York, New York, 10016, United States

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • Tulane Medical Center

    New Orleans, Louisiana, 70112, United States

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

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