Glofitamab combined with selinexor: 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Complete Response Rate (CRR) — Up to approximately 2 years 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.
Trial sites (1)
Facility
City
Region
Status
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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