EZH2 Inhibitor Zeprumetostat in Combination Therapy for Patients With Relapsed or Refractory Matu⦠(NCT07339527) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
EZH2 Inhibitor Zeprumetostat in Combination Therapy for Patients With Relapsed or Refractory Mature T-cell and NK-cell Lymphomas
60 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 ā„ 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 conseā¦
What they're measuring
1
DLT for Phase 1b
Timeframe: The first cycle after administration (each cycle is 28 days)
2
Overall response rate(ORR) for Phase 2
Timeframe: Up to 24 months
3
RP2D for phase Ib
Timeframe: The first cycle after administration (each cycle is 28 days)