A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed/Refractory Large B-Cell Lymphoma

NCT07599423 | Not Yet Recruiting Phase 2

• 1 other identifier: ML46548
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).

Conditions

Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Event-Free Survival (EFS)

  EFS is defined as the time from randomization to the earliest date of disease progression according to the Lugano Classification (2014), commencement of new anti-lymphoma therapy, or death from any cause, as determined by the investigator.

  From randomization until the first occurrence of an EFS event (disease progression, new therapy, or death), assessed up to approximately 48 months.

Secondary Outcomes (10)

• Complete Response (CR) Rate

  From randomization to the end of study, up to approximately 48 months.

• Objective Response Rate (ORR)

  From randomization to the end of study, up to approximately 48 months.

• Progression-Free Survival (PFS)

  From randomization until disease progression or death, assessed up to approximately 48 months.

• Duration of Response (DOR)

  From the date of first documented objective response until disease progression or death, assessed up to approximately 48 months.

• Duration of Complete Response (DOCR)

  From the date of first documented CR until disease progression or death, assessed up to approximately 48 months.

Study Arms (2)

Glofit-GemOx

EXPERIMENTAL

Drug: Obinutuzumab; Drug: Glofitamab; Drug: Gemcitabine; Drug: Oxaliplatin

SoC

ACTIVE COMPARATOR

Drug: Salvage Chemotherapy (Investigator's Choice); Drug: Autologous Stem Cell Transplantation (ASCT)

Interventions

Obinutuzumab DRUG

A single 1000 mg dose is administered intravenously as pretreatment on Day 1 of Cycle 1 (7 days prior to the first glofitamab dose) to deplete peripheral B-cells and mitigate the risk of cytokine release syndrome (CRS).

Glofit-GemOx

Glofitamab DRUG

Glofitamab is administered intravenously using a step-up dosing schedule to mitigate CRS: Cycle 1 Day 8: 2.5 mg. Cycle 1 Day 15: 10 mg. Cycle 2-12 Day 1: 30 mg (target dose). Treatment continues for a maximum of 12 cycles (21-day cycles) or until disease progression/unacceptable toxicity.

Glofit-GemOx

Gemcitabine DRUG

Administered intravenously at 1000 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8).

Glofit-GemOx

Oxaliplatin DRUG

Administered intravenously at 100 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8).

Glofit-GemOx

Salvage Chemotherapy (Investigator's Choice) DRUG

Participants in the SOC arm will receive up to 2 cycles of investigator's choice salvage therapy among the following regimens: ICE ± R, DHAP ± R, GDP ± R, ESHAP ± R, GemOx ± R, or MINE ± R .

SoC

Autologous Stem Cell Transplantation (ASCT) DRUG

Participants in the SOC arm who achieve a CR or PR after salvage therapy will proceed to ASCT. This includes a conditioning regimen (e.g., BEAM) followed by autologous stem cell rescue and a recovery period.

SoC

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent Form.
• Age 18 years or older at the time of signing the Informed Consent Form.
• Histologically proven large B-cell lymphoma (LBCL), including transformation from follicular lymphoma.
• Relapsed or refractory disease after first-line chemoimmunotherapy, defined as refractory disease (no complete remission to first-line therapy, progressive disease as best response, stable disease after 3-4 cycles, or partial response after 6-8 cycles/progression within 12 months) or relapsed disease (complete remission followed by biopsy-proven relapse within 12 months of initiating first-line therapy).
• No known history or suspicion of central nervous system (CNS) involvement by lymphoma.
• Life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• At least one bi-dimensionally measurable nodal lesion (1.5 cm or larger) or extranodal lesion (1 cm or larger) as measured on a CT scan.
• Negative HIV test at screening.
• Adequate hematologic function defined as hemoglobin 9.0 g/dL or higher without transfusion in the past 7 days, absolute neutrophil count 1.0 x 10\^9/L or higher, and platelet count 75 x 10\^9/L or higher.
• Adequate organ function defined as estimated creatinine clearance 60 mL/min or higher, ALT/AST 2.5 times the upper limit of normal (ULN) or lower, and total bilirubin 1.5 mg/dL or lower (or 3 x ULN or lower in subjects with Gilbert's syndrome).
• Cardiac ejection fraction greater than 50%, no evidence of pericardial effusion, and no clinically significant electrocardiogram findings.
• No clinically significant pleural effusion.
• Baseline oxygen saturation greater than 92% on room air.
• Able to understand and complete study-related questionnaires.

You may not qualify if:

• Contraindication to glofitamab components or a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
• Not eligible for autologous stem cell transplantation (ASCT).
• Prior solid organ transplantation.
• History of Richter's transformation or of indolent disease to diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL).
• Peripheral neuropathy assessed to be greater than Grade 1 at enrollment.
• Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.
• Use of any investigational therapy for treating cancer within 28 days prior to Cycle 1, any monoclonal antibody within 3 months, or systemic immunotherapeutic agents within 4 weeks or five half-lives (whichever is shorter).
• Prior radiotherapy to the mediastinal or pericardial region.
• History of autologous or allogeneic stem cell transplant.
• Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better, except for alopecia and anorexia.
• Administration of a live, attenuated vaccine within 4 weeks before the first study treatment administration.
• Received more than one line of therapy for DLBCL.
• Corticosteroid use greater than 50 mg/day of prednisone or equivalent for purposes other than lymphoma symptom control.
• Recent major surgery within 4 weeks before the first study treatment.
• History of other malignancy that could affect compliance or interpretation of results, with exceptions for adequately treated low-grade or in situ carcinomas and malignancies in remission for at least 2 years.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Interventions

obinutuzumab; glofitamab; Gemcitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Central Study Contacts

Changju Qu

CONTACT

+86-512-67975805; qcj310@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)