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.
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.
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.
Patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have previously received at least two lines of systemic therapy.
Cohort
Prospective
Glofitamab combined with selinexor
DrugPatients 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.
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.
Objective Response Rate (ORR)
Proportion of patients achieving a best overall response of partial response (PR) or complete response (CR) as assessed by the investigator according to the 2014 Lugano Classification criteria.
Duration of Complete Response (DoCR)
Time from the first documented complete response (CR) to the first documented disease progression or death from any cause, whichever occurs first.
Progression-Free Survival (PFS)
Time from the start of study treatment to the first documented disease progression or death from any cause, whichever occurs first.
Overall Survival (OS)
Time from the start of study treatment to death from any cause.
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
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
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