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NCT Number: NCT07339527

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zeprumetostat

Drug

350mg, po, bid

golidocitinib

Drug

Cohort 1: Golidocitinib: 150mg, po, qd

Chidamide

Drug

Cohort 2: Chidamide: 20mg, po, biw

Primary outcomes

  1. DLT for Phase 1b

    Time frame: The first cycle after administration (each cycle is 28 days)

    To identify the dose-limiting toxicity

  2. Overall response rate(ORR) for Phase 2

    Time frame: Up to 24 months

    The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.

  3. RP2D for phase Ib

    Time frame: The first cycle after administration (each cycle is 28 days)

    To identify the recommended phase 2 dose

Secondary outcomes

  1. Complete response rate (CRR)

    Time frame: Up to 24 months

    Defined as the proportion of patients who achieve complete remission as the best response

  2. Duration of Response(DOR)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

  3. Progression-free survival(PFS)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

  4. Overall survival(OS)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai, MD. PhD.

CONTACT

[email protected]

+862087342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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