Mature T-cell and NK-cell LymphomaPhase 1/2NCT07339527
EZH2 Inhibitor Zeprumetostat in Combination Therapy for Patients With Relapsed or Refractory Mature T-cell and NK-cell Lymphomas
A Phase 1/2 study testing Zeprumetostat, Golidocitinib and Chidamide in people with Mature T-cell and NK-cell Lymphoma, run by Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mature T-cell and NK-cell Lymphoma
- What is being tested?
- Zeprumetostat, Golidocitinib and Chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jan 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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
- Being tested
- Zeprumetostat, Golidocitinib, Chidamide
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZeprumetostatDrug
350mg, po, bid
GolidocitinibDrug
Cohort 1: Golidocitinib: 150mg, po, qd
ChidamideDrug
Cohort 2: Chidamide: 20mg, po, biw
| Study group | Role | What they receive |
|---|---|---|
| Zeprumetostat Combined with Golidocitinib or Chidamide | Experimental | 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. Receives: Drug: Zeprumetostat; Drug: Golidocitinib; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT for Phase 1b
To identify the dose-limiting toxicity
Measured: The first cycle after administration (each cycle is 28 days)
Overall response rate(ORR) for Phase 2
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Measured: Up to 24 months
RP2D for phase Ib
To identify the recommended phase 2 dose
Measured: The first cycle after administration (each cycle is 28 days)
Secondary outcomes (4)
Complete response rate (CRR)
Defined as the proportion of patients who achieve complete remission as the best response
Measured: Up to 24 months
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 4 years
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 4 years
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mature T-cell and NK-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339527
- Sponsor's protocol ID
- B2025-804
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07339527
- Acronym / sponsor ID
- B2025-804
- Conditions
- Mature T-cell and NK-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zeprumetostat Combined with Golidocitinib or Chidamide | Experimental | Drug: Zeprumetostat, Drug: Golidocitinib, Drug: ChidamideIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zeprumetostat350mg, po, bid | Drug | Zeprumetostat Combined with Golidocitinib or Chidamide |
| GolidocitinibCohort 1: Golidocitinib: 150mg, po, qd | Drug | Zeprumetostat Combined with Golidocitinib or Chidamide |
| ChidamideCohort 2: Chidamide: 20mg, po, biw | Drug | Zeprumetostat Combined with Golidocitinib or Chidamide |
Primary outcome
DLT for Phase 1b
Time frame: The first cycle after administration (each cycle is 28 days)
To identify the dose-limiting toxicity
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.
RP2D for phase Ib
Time frame: The first cycle after administration (each cycle is 28 days)
To identify the recommended phase 2 dose
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zeprumetostat, Golidocitinib and Chidamide in people with Mature T-cell and NK-cell Lymphoma, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingqing Cai, MD. PhD. (+862087342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT for Phase 1b (time frame: The first cycle after administration (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.