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Not yet recruiting NCT07339527

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

Phase I / Phase II Interventional Mature T-cell and NK-cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zeprumetostat, Golidocitinib, Chidamide.
Who it may be relevant to
Registry conditions: Mature T-cell and NK-cell Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Multicenter, Exploratory Clinical Study of the EZH2 Inhibitor Zeprumetostat in Combination Therapy for Patients With Relapsed or Refractory Mature T-cell and NK-cell Lymphomas.

Overview

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.

Interventions

  • Drug Zeprumetostat
    350mg, po, bid
  • Drug Golidocitinib
    Cohort 1: Golidocitinib: 150mg, po, qd
  • Drug Chidamide
    Cohort 2: Chidamide: 20mg, po, biw

Primary outcome measures

  • DLT for Phase 1b [Time frame: The first cycle after administration (each cycle is 28 days)]
  • Overall response rate(ORR) for Phase 2 [Time frame: Up to 24 months]
  • RP2D for phase Ib [Time frame: The first cycle after administration (each cycle is 28 days)]
Secondary outcome measures (4)
  • Complete response rate (CRR) [Time frame: Up to 24 months]
  • Duration of Response(DOR) [Time frame: Up to 4 years]
  • Progression-free survival(PFS) [Time frame: Up to 4 years]
  • Overall survival(OS) [Time frame: Up to 4 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07339527 · B2025-804

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗