Diffuse Large B-Cell Lymphoma (DLBCL)Glofit-SelNCT07669194
Glofitamab Combined With Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
An observational study of Diffuse Large B-Cell Lymphoma (DLBCL), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- Glofitamab combined with selinexor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Jiefeng Tong, 13588710821, jeffytong@163.com
About this study
Official title: Observational Real-World Study of Glofitamab Combined With Selinexor for Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
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.
Read the detailed description
Currently, patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have failed at least two lines of systemic therapy have a poor prognosis, and there is a significant clinical need for new treatment options. Glofitamab and selinexor have both demonstrated clinical activity as single agents in R/R DLBCL. Because their mechanisms of action are complementary and their toxicity profiles do not overlap significantly, this combination holds the potential to further improve outcomes. Therefore, this study plans to assess the efficacy and safety of glofitamab in combination with selinexor for the treatment of R/R DLBCL patients who have previously received at least two lines of systemic therapy. Enrolled patients will receive study treatments for up to 12 cycles, with each 21-day period being one cycle. Cycle 1 involves obinutuzumab pre-treatment and step-up dosing of glofitamab. From Cycle 2 to Cycle 12, patients will receive glofitamab in combination with oral selinexor. Interim efficacy evaluations will be conducted during the treatment. At the end of the 12 cycles or upon treatment discontinuation, a final efficacy evaluation will be conducted, followed by a long-term follow-up period.
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Being tested
- Glofitamab combined with selinexor
- Keywords
- Relapsed/Refractory, Glofitamab, Selinexor
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glofitamab combined with selinexorDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Glofitamab combined with selinexor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 2 years
Secondary outcomes (5)
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.
Measured: Up to approximately 2 years
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.
Measured: Up to approximately 2 years
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.
Measured: Up to approximately 2 years
Overall Survival (OS)
Time from the start of study treatment to death from any cause.
Measured: Up to approximately 2 years
Incidence and Severity of Adverse Events (AEs)
Incidence and severity of AEs graded according to NCI CTCAE v5.0, with Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) graded according to the ASTCT 2019 consensus criteria.
Measured: From baseline up to 90 days after the last dose of study treatment (assessed up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Provincial Tongde Hospital, Affiliated Hospital of Jiaxing University, Shaoxing People's Hospital, Shaoxing Central Hospital, Zhuji People's Hospital of Zhejiang Province
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669194
- Sponsor's protocol ID
- 2026-0473
- Acronym
- Glofit-Sel
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Real-World Study of Glofitamab Combined With Selinexor for Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
- ClinicalTrials.gov ID
- NCT07669194
- Acronym / sponsor ID
- Glofit-Sel / 2026-0473
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Keywords
- Relapsed/Refractory, Glofitamab, Selinexor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Provincial Tongde Hospital, Affiliated Hospital of Jiaxing University, Shaoxing People's Hospital, Shaoxing Central Hospital, Zhuji People's Hospital of Zhejiang Province
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Currently, patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have failed at least two lines of systemic therapy have a poor prognosis, and there is a significant clinical need for new treatment options. Glofitamab and selinexor have both demonstrated clinical activity as single agents in R/R DLBCL. Because their mechanisms of action are complementary and their toxicity profiles do not overlap significantly, this combination holds the potential to further improve outcomes. Therefore, this study plans to assess the efficacy and safety of glofitamab in combination with selinexor for the treatment of R/R DLBCL patients who have previously received at least two lines of systemic therapy. Enrolled patients will receive study treatments for up to 12 cycles, with each 21-day period being one cycle. Cycle 1 involves obinutuzumab pre-treatment and step-up dosing of glofitamab. From Cycle 2 to Cycle 12, patients will receive glofitamab in combination with oral selinexor. Interim efficacy evaluations will be conducted during the treatment. At the end of the 12 cycles or upon treatment discontinuation, a final efficacy evaluation will be conducted, followed by a long-term follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glofitamab + Selinexor Cohort | – | Drug: Glofitamab combined with selinexorPatients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) receiving up to 12 cycles of glofitamab in combination with selinexor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glofitamab combined with selinexorPatients 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. | Drug | Glofitamab + Selinexor Cohort |
Primary outcome
Complete Response Rate (CRR)
Time frame: 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.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Duration of Complete Response (DoCR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Incidence and Severity of Adverse Events (AEs)
Time frame: From baseline up to 90 days after the last dose of study treatment (assessed up to approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Diffuse Large B-Cell Lymphoma (DLBCL)
RecruitingPhase 1
A Study of ARC-02 in B-cell NHL
B-cell Non Hodgkin Lymphoma
Active, not recruitingPhase 2
Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Diffuse Large B-cell Lymphoma (DLBCL), Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
Not yet recruitingPhase 1
A Multicenter, Phase I Study to Evaluate the Feasibility and Safety of Autologous Cytokine-Induced Killer Cells (CIK_D332) in Combination With Tafasitamab and Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma (DLBCL)
RecruitingPhase 2
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Large B-cell Lymphoma
RecruitingPhase 2
A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma
Diffuse Large B Cell Lymphoma (DLBCL), High Grade B Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-Cell Lymphoma (DLBCL), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiefeng Tong (13588710821, jeffytong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (CRR) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.