Glofitamab Combined With Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

NCT07669194 | Not Yet Recruiting

• 1 other identifier: 2026-0473
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the efficacy and safety of glofitamab in combination with selinexor for the treatment of relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in patients who have received at least two prior lines of systemic therapy.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Keywords

Relapsed/Refractory; Glofitamab; Selinexor

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR)

  Proportion of patients achieving a best overall response of complete response (CR) as assessed by the investigator according to the 2014 Lugano Classification criteria based on PET/CT or CT scans.

  Up to approximately 2 years

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Up to approximately 2 years

• Duration of Complete Response (DoCR)

  Up to approximately 2 years

• Progression-Free Survival (PFS)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

• Incidence and Severity of Adverse Events (AEs)

  From baseline up to 90 days after the last dose of study treatment (assessed up to approximately 2 years)

Study Arms (1)

Glofitamab + Selinexor Cohort

Patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) receiving up to 12 cycles of glofitamab in combination with selinexor.

Drug: Glofitamab combined with selinexor

Interventions

Glofitamab combined with selinexor DRUG

Patients receive obinutuzumab 1000 mg intravenously (IV) on Day 1 of Cycle 1 to mitigate cytokine release syndrome (CRS) risk. Glofitamab is administered IV with step-up dosing at 2.5 mg on Day 8 and 10 mg on Day 15 of Cycle 1, followed by a target dose of 30 mg on Day 1 of Cycles 2 through 12. Selinexor is administered orally at 60 mg on Days 1 and 3 of each week, starting from Cycle 2 through Cycle 12. Each cycle is 21 days. The total fixed duration of treatment is 12 cycles.

Glofitamab + Selinexor Cohort

Eligibility Criteria

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

Study Population

Patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have previously received at least two lines of systemic therapy.

You may qualify if:

• Age 18 years and older at the time of informed consent.
• Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).
• Relapsed or refractory disease, having previously received at least two lines of systemic therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
• Presence of measurable disease.
• Adequate hematologic, hepatic, and renal function.
• Willingness to use effective contraception methods during the study and for a specified period after the last dose.
• Willing and able to provide written informed consent and comply with the study protocol.

You may not qualify if:

• Prior treatment with any CD20/CD3 bispecific antibodies or XPO1 inhibitors.
• Current or prior history of central nervous system (CNS) involvement by lymphoma or other significant CNS diseases.
• Active and uncontrolled systemic infections, including known HIV infection, active Hepatitis B virus (HBV), or active Hepatitis C virus (HCV) infection.
• Active autoimmune diseases requiring systemic immunosuppressive therapy.
• Clinically significant, severe, or uncontrolled cardiovascular diseases.
• Other active invasive malignancies within the past 2 years (with exceptions for adequately treated localized cancers).
• Recent major surgery or receipt of live attenuated vaccines within a specified timeframe prior to the study.
• Severe gastrointestinal conditions that may significantly affect the absorption of oral medications.
• Known severe allergic reactions to any of the study drugs or their excipients.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• Shaoxing People's Hospital: collaborator
• Shaoxing Central Hospital: collaborator
• Zhuji People's Hospital of Zhejiang Province: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence

Interventions

selinexor

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jiefeng Tong

CONTACT

13588710821; jeffytong@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 25, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)