EZH2 Inhibitor Zeprumetostat in Combination Therapy for Patients With Relapsed or Refractory Mature T-cell and NK-cell Lymphomas

NCT ID: NCT07339527

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2030-01-01

Brief Summary

This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of EZH2 inhibitor Zeprumetostat in combination therapy for patients with relapsed or refractory mature T-cell and NK-cell lymphomas.

Conditions

Mature T-cell and NK-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zeprumetostat Combined with Golidocitinib or Chidamide

In Cohort 1, patients will receive Zeprumetostat in combination with Golidocitinib, with an initial dose of 350mg of Zeprumetostat. Each treatment cycle is 28 days. The Zeprumetostat will be combined with Golidocitinib at the RP2D dose level for an extension study. In Cohort 2, patients will receive Zeprumetostat in combination with Chidamide, with an initial dose of 350mg of Zeprumetostat. Each treatment cycle is 28 days. The Zeprumetostat will be combined with Chidamide at the RP2D dose level for an extension study.

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

Cohort 2: Chidamide: 20mg, po, biw

Zeprumetostat

Intervention Type: DRUG

350mg, po, bid

Golidocitinib

Intervention Type: DRUG

Cohort 1: Golidocitinib: 150mg, po, qd

Interventions

Chidamide

Cohort 2: Chidamide: 20mg, po, biw

Intervention Type: DRUG

Zeprumetostat

350mg, po, bid

Intervention Type: DRUG

Golidocitinib

Cohort 1: Golidocitinib: 150mg, po, qd

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
• Age ≥ 18 years
• Pathologically confirmed mature T-cell and NK-cell lymphomas.
• Using the Lugano 2014 criteria, the patient must have at least one measurable or evaluable lesion
• Participants must have experienced disease progression, treatment failure, or intolerance following standard therapy. Patients with ALCL are required to have previously received anti-CD30-targeted therapy, while patients with NKTCL must have previously been treated with pegaspargase or L-asparaginase.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Adequate organ and bone marrow function

Exclusion Criteria

• Lymphoma involvement in the central nervous system or meninges
• Active infections
• Prior treatment with an EZH2 inhibitor or an EZH1/2 dual inhibitor that was discontinued due to intolerance to toxicity;
• For patients enrolled in Cohort 1, prior treatment with a JAK inhibitor that was discontinued due to intolerance to toxicity;
• For patients enrolled in Cohort 2, prior treatment with an HDAC inhibitor that was discontinued due to intolerance to toxicity.
• History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
• Patients with mental disorders or those unable to provide informed consent
• Any other condition deemed by the investigator to be unsuitable for study enrollment;
• Pregnant or breastfeeding women, and subjects of childbearing potential who are unwilling to use contraception;
• Individuals with a known hypersensitivity to any of the investigational drugs.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qingqing Cai, MD. PhD.

Role: CONTACT

caiqq@sysucc.org.cn

+862087342823

Other Identifiers

B2025-804

Identifier Type: -

Identifier Source: org_study_id