Single-Arm Clinical Study of EZH2i in Combination With Glofitamab + GemOx in Patients With Relapsed/ Refractory DLBCL

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

Study Overview

• Status: Not yet recruiting
• Conditions: DLBCL
• Intervention / Treatment: Drug: EZH2i+GLofit-GemOx

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lei Fan; Phone Number: +86 13813976136; Email: fanlei3014@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital with Nanjing Medical University
      • Principal Investigator: Lei Fan
      • Contact: Lei Fan; Phone Number: +86 13813976136; Email: fanlei3014@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years, male or female;
2. Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
3. Relapsed/refractory (R/R) disease；
4. At least one prior line of therapy containing rituximab;
5. Subjects must have at least one measurable lesion;
6. ECOG PS 0-2;
7. Life expectancy ≥ 3 months;
8. Adequate organ and bone marrow function, without severe hematopoietic abnormalities or cardiac, pulmonary, hepatic, renal, thyroid dysfunction, or immunodeficiencies;
9. 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;
10. Signed informed consent form (ICF), voluntarily agreeing to participate in this study.

Exclusion Criteria:

1. Patient is a candidate for hematopoietic stem cell transplantation.
2. Prior allogeneic hematopoietic stem cell transplantation.
3. Primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma.
4. History of severe hypersensitivity or anaphylactic reaction to humanized or murine monoclonal antibodies.
5. Prior treatment with an EZH2 inhibitor, and/or an anti-CD20 and CD3 bispecific antibody, and/or GemOx (gemcitabine and oxaliplatin).
6. History of other malignancies within the past 2 years requiring systemic therapy.
7. Receipt of systemic anti-neoplastic therapy, including chemotherapy, immunotherapy, biologic therapy, etc., within 14 days prior to the start of study treatment.
8. Major surgery (excluding diagnostic procedures) within 28 days prior to the start of study treatment.
9. 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.)
10. 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).
11. Any active infection requiring systemic anti-infective therapy within 14 days prior to the start of study treatment.
12. Presence of any uncontrolled comorbid conditions that may affect compliance with the study protocol, including major cardiovascular disease, bleeding disorders, etc.
13. Active hepatitis B virus (HBV) infection (HBV DNA positive) or hepatitis C virus (HCV) infection.
14. Known history of human immunodeficiency virus (HIV) positivity.
15. Inability to swallow oral medication, or any other factor affecting oral drug administration and absorption.
16. Known history of hypersensitivity to the study drug.
17. Pregnant or breastfeeding women.
18. Any other condition deemed inappropriate for inclusion by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EZH2i+Glofit-GemOx	Drug: EZH2i+GLofit-GemOx; EZH2i+GLofit-GemOx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete response rate, CRR	From first dose to end of treatment (assessed up to 12 months)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MA-DLBCL-II-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No