NCT05364424CompletedPhase 1
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
A Phase IB, Open-Label, Multicenter, Single Arm Study Evaluating the Preliminary Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Patients With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 3 May 2022
- Start date
- 4 Nov 2022
- Primary completion date
- 15 Oct 2025
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05364424
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 43
- From 4 Nov 2022 to the primary completion date, 15 Oct 2025
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with more than one prior line of therapy for DLBCL
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
- 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
- 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
- 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
Other illness
- Peripheral neuropathy assessed to be Grade \> 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
- 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
- Active autoimmune disease requiring treatment
- Clinically significant history of cirrhotic liver disease
Other
- Primary mediastinal B-cell lymphoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University Of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Tulane Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| New York University Langone Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Chao Family Comprehensive Cancer Center UCI Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Memorial Cancer Institute at Memorial West Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| Umass Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.