DLBCLPhase 1/2NCT07643805
Single-Arm Clinical Study of EZH2i in Combination With Glofitamab + GemOx in Patients With Relapsed/ Refractory DLBCL
A Phase 1/2 study testing EZH2i+GLofit-GemOx in people with DLBCL, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Single-Arm Clinical Study of Zeprumetostat in Combination with Glofitamab + GemOx in Patients with Relapsed/ Refractory DLBCL Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DLBCL
- What is being tested?
- EZH2i+GLofit-GemOx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 30 Sep 2030
- Phase
- Phase 1/2
- 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
Who may be able to join
- Age ≥ 18 years, male or female;
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
- Relapsed/refractory (R/R) disease；
- At least one prior line of therapy containing rituximab;
- Subjects must have at least one measurable lesion;
- ECOG PS 0-2;
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- Life expectancy ≥ 3 months;
- Adequate organ and bone marrow function, without severe hematopoietic abnormalities or cardiac, pulmonary, hepatic, renal, thyroid dysfunction, or immunodeficiencies;
- Female subjects of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of study drug; WOCBP subjects and male subjects with WOCBP partners must agree to practice effective contraceptive measures from the time of signing the informed consent form (ICF) until 6 months after the last dose of study drug;
- Signed informed consent form (ICF), voluntarily agreeing to participate in this study.
Who cannot join
- Patient is a candidate for hematopoietic stem cell transplantation.
- Prior allogeneic hematopoietic stem cell transplantation.
- Primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma.
- History of severe hypersensitivity or anaphylactic reaction to humanized or murine monoclonal antibodies.
- Prior treatment with an EZH2 inhibitor, and/or an anti-CD20 and CD3 bispecific antibody, and/or GemOx (gemcitabine and oxaliplatin).
- History of other malignancies within the past 2 years requiring systemic therapy.
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- Receipt of systemic anti-neoplastic therapy, including chemotherapy, immunotherapy, biologic therapy, etc., within 14 days prior to the start of study treatment.
- Major surgery (excluding diagnostic procedures) within 28 days prior to the start of study treatment.
- Presence of any active, known, or suspected autoimmune disease. (Subjects who are in a stable condition and do not require systemic immunosuppressive therapy are permitted to enroll.)
- Use of immunosuppressive agents, including systemic corticosteroids, within 14 days prior to study drug administration (use of ≤10 mg/day prednisone or equivalent is permitted).
- Any active infection requiring systemic anti-infective therapy within 14 days prior to the start of study treatment.
- Presence of any uncontrolled comorbid conditions that may affect compliance with the study protocol, including major cardiovascular disease, bleeding disorders, etc.
- Active hepatitis B virus (HBV) infection (HBV DNA positive) or hepatitis C virus (HCV) infection.
- Known history of human immunodeficiency virus (HIV) positivity.
- Inability to swallow oral medication, or any other factor affecting oral drug administration and absorption.
- Known history of hypersensitivity to the study drug.
- Pregnant or breastfeeding women.
- Any other condition deemed inappropriate for inclusion by the investigator.
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
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Lei Fan, 13813976136 ext. +86, fanlei3014@126.com
Lei Fan
About this study
Official title: A Prospective, Single-Arm, Phase Ib/II Clinical Study of the EZH2 Inhibitor in Combination With Glofitamab Plus GemOx for the Treatment of Relapsed/Refractory DLBCL
Single-Arm Clinical Study of Zeprumetostat in Combination with Glofitamab + GemOx in Patients with Relapsed/ Refractory DLBCL
- Conditions
- DLBCL
- Being tested
- EZH2i+GLofit-GemOx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZH2i+GLofit-GemOxDrug
EZH2i+GLofit-GemOx
| Study group | Role | What they receive |
|---|---|---|
| EZH2i+Glofit-GemOx | Experimental | Not described Receives: Drug: EZH2i+GLofit-GemOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate, CRR
Measured: From first dose to end of treatment (assessed up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCLStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Fan, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643805
- Sponsor's protocol ID
- MA-DLBCL-II-005
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Phase Ib/II Clinical Study of the EZH2 Inhibitor in Combination With Glofitamab Plus GemOx for the Treatment of Relapsed/Refractory DLBCL
- ClinicalTrials.gov ID
- NCT07643805
- Acronym / sponsor ID
- MA-DLBCL-II-005
- Conditions
- DLBCL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 12 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.
Single-Arm Clinical Study of Zeprumetostat in Combination with Glofitamab + GemOx in Patients with Relapsed/ Refractory DLBCL
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EZH2i+Glofit-GemOx | Experimental | Drug: EZH2i+GLofit-GemOx |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years, male or female;
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
- Relapsed/refractory (R/R) disease；
- At least one prior line of therapy containing rituximab;
- Subjects must have at least one measurable lesion;
Key exclusion criteria (18 listed)
- Patient is a candidate for hematopoietic stem cell transplantation.
- Prior allogeneic hematopoietic stem cell transplantation.
- Primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma.
- History of severe hypersensitivity or anaphylactic reaction to humanized or murine monoclonal antibodies.
- Prior treatment with an EZH2 inhibitor, and/or an anti-CD20 and CD3 bispecific antibody, and/or GemOx (gemcitabine and oxaliplatin).
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 |
|---|---|---|
| EZH2i+GLofit-GemOxEZH2i+GLofit-GemOx | Drug | EZH2i+Glofit-GemOx |
Primary outcome
Complete response rate, CRR
Time frame: From first dose to end of treatment (assessed up to 12 months)
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 12 Jun 2026.
- Individual participant dataSharing planned: No
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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?
A Phase 1/2 study testing EZH2i+GLofit-GemOx in people with DLBCL, run by The First Affiliated Hospital with Nanjing Medical University 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 10 inclusion and 18 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 12 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lei Fan (13813976136 ext. +86, fanlei3014@126.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: From first dose to end of treatment (assessed up to 12 months)). 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 12 Jun 2026.