New combo therapy shows promise for Tough-to-Treat lymphoma
NCT ID NCT05364424
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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43 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Oct 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Chao Family Comprehensive Cancer Center UCI
Orange, California, 92868, United States
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Memorial Cancer Institute at Memorial West
Pembroke Pines, Florida, 33028, United States
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New York University Langone Medical Center
New York, New York, 10016, United States
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The University of Chicago
Chicago, Illinois, 60637, United States
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Tulane Medical Center
New Orleans, Louisiana, 70112, United States
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UMASS Memorial Medical Center
Worcester, Massachusetts, 01655, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Proton beams vs. X-Rays: can a pricier radiation spare hearts and prevent second cancers?
- New antibody JS203 takes on rituximab in Head-to-Head lymphoma trial
- Can 'Memory-Enhanced' immune cells outsmart lymphoma?
- Can a new drug combo outperform standard chemo for Hard-to-Treat lymphoma?
- Can immune cells plus a checkpoint drug outsmart lymphoma?
- Can a Two-Drug combo keep aggressive lymphoma at bay?