PTCL-NOSPhase 1/2NCT07724782
Multi-Cohort Study of Zeprumetostat Combinations for Relapsed/Refractory PTCL
A Phase 1/2 study testing Zeprumetostat( an EZH2 inhibitor) + X in people with PTCL-NOS, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a single-arm, multi-cohort, multicenter, phase Ib/IIa clinical study designed to evaluate the safety and efficacy of Zeprumetostat (an EZH2 inhibitor) in combination with different therapeutic agents/regimens - specifically, the JAK1 inhibitor golidocitinib and the GemOx chemotherapy regimen (gemcitabine plus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTCL-NOS
- What is being tested?
- Zeprumetostat( an EZH2 inhibitor) + X
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Jul 2031
- 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
- Age 18 years or older, both males and females are eligible;
- Histologically confirmed peripheral T-cell lymphoma (PTCL) including PTCL-NOS and TFHL that has relapsed or is refractory after at least one line of systemic therapy. The definitions are as follows:
- Relapse: Patients who achieved a Complete Response (CR) in previous treatments and have new lesions at the original site or elsewhere; Refractory: Patients who did not achieve CR after adequate treatment. For nasal-type NK/T-cell lymphoma, previous treatments must have included a chemotherapy regimen containing asparaginase;
- Patients who have undergone prior hematopoietic stem cell transplantation are allowed;
- ECOG PS 0-2
- Life expectancy greater than 3 months.
Show all 9Show fewer
- Adequate organ function
- Contraception during study
- Informed consented
Who cannot join
- Prior treatment with EZH2 inhibitors or EZH1/2 inhibitors before enrollment;
- Peripheral T-cell lymphoma of subtypes other than PTCL-NOS and TFHL;
- History of other primary invasive malignancies that have not been in remission or have been in remission for no more than 3 years;
- Central nervous system involvement (meningeal or parenchymal);
- Known hypersensitivity to any study drugs;
- Participation in another clinical trial of an investigational drug within 4 weeks prior to the start of the study.
Show all 16Show fewer
- Pregnant or lactation
- Active infection.
- Diseases and medical history:
- Requires continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers
- Has multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Has a history of psychoactive substance abuse that cannot be discontinued
- Has any severe and/or uncontrolled disease.
- Uncontrollable autoimmune disease,
- Not able to comply to the protocol for mental or other unknown reasons
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi Cohort Exploratory Clinical Study of the EZH2 Inhibitor Zeprumetostat Combination Regimen in Relapsed/Refractory Peripheral T Cell Lymphoma
This is a single-arm, multi-cohort, multicenter, phase Ib/IIa clinical study designed to evaluate the safety and efficacy of Zeprumetostat (an EZH2 inhibitor) in combination with different therapeutic agents/regimens - specifically, the JAK1 inhibitor golidocitinib and the GemOx chemotherapy regimen (gemcitabine plus oxaliplatin) - in patients with relapsed or refractory peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and T-follicular helper cell lymphoma (TFHL). The trial comprises a phase Ib dose-escalation phase and a phase IIa dose-expansion phase. Two combination cohorts are established: Cohort A (zemitostatin + golidocitinib) and Cohort B (zemitostatin + GemOx). Subjects will be randomly assigned to either Cohort A or Cohort B.
- Conditions
- PTCL-NOS
- Being tested
- Zeprumetostat( an EZH2 inhibitor) + X
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zeprumetostat( an EZH2 inhibitor) + XDrug
Zeprumetostat( an EZH2 inhibitor) + JAK1 inhibitor or GemOx
| Study group | Role | What they receive |
|---|---|---|
| Zeprumetostat + X | Experimental | Zeprumetostat+JAK1 inhibitor/GemoX Receives: Drug: Zeprumetostat( an EZH2 inhibitor) + X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of DLT events (Phase Ib)
A Phase Ib Dose-Finding Study of Zeprumetostat in Combination Using a 3+3 Design
Measured: At the end of Cycle 1 (each cycle is 21 days)
Overall response rate (Phase Ⅱ)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment EZH2+JAK1/GeMox
Measured: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Secondary outcomes (5)
Complete response rate
Complete Response Rate (CRR) is defined as the proportion of subjects who achieve CR after treatment EZH2+JAK1/GeMox
Measured: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Duration of response
Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders.
Measured: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Progression free survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first
Measured: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Overall survival
Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first
Measured: Through study completion, an average of 3 years after EZH2+JAK1/GemOx (Day 1)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events
Measured: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCL-NOSStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724782
- Sponsor's protocol ID
- MA-PTCL-II-003
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Cohort Exploratory Clinical Study of the EZH2 Inhibitor Zeprumetostat Combination Regimen in Relapsed/Refractory Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07724782
- Acronym / sponsor ID
- MA-PTCL-II-003
- Conditions
- PTCL-NOS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 24 Jul 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 single-arm, multi-cohort, multicenter, phase Ib/IIa clinical study designed to evaluate the safety and efficacy of Zeprumetostat (an EZH2 inhibitor) in combination with different therapeutic agents/regimens - specifically, the JAK1 inhibitor golidocitinib and the GemOx chemotherapy regimen (gemcitabine plus oxaliplatin) - in patients with relapsed or refractory peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and T-follicular helper cell lymphoma (TFHL). The trial comprises a phase Ib dose-escalation phase and a phase IIa dose-expansion phase. Two combination cohorts are established: Cohort A (zemitostatin + golidocitinib) and Cohort B (zemitostatin + GemOx). Subjects will be randomly assigned to either Cohort A or Cohort B.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zeprumetostat + X | Experimental | Drug: Zeprumetostat( an EZH2 inhibitor) + XZeprumetostat+JAK1 inhibitor/GemoX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older, both males and females are eligible;
- Histologically confirmed peripheral T-cell lymphoma (PTCL) including PTCL-NOS and TFHL that has relapsed or is refractory after at least one line of systemic therapy. The definitions are as follows:
- Relapse: Patients who achieved a Complete Response (CR) in previous treatments and have new lesions at the original site or elsewhere; Refractory: Patients who did not achieve CR after adequate treatment. For nasal-type NK/T-cell lymphoma, previous treatments must have included a chemotherapy regimen containing asparaginase;
- Patients who have undergone prior hematopoietic stem cell transplantation are allowed;
- ECOG PS 0-2
Key exclusion criteria (16 listed)
- Prior treatment with EZH2 inhibitors or EZH1/2 inhibitors before enrollment;
- Peripheral T-cell lymphoma of subtypes other than PTCL-NOS and TFHL;
- History of other primary invasive malignancies that have not been in remission or have been in remission for no more than 3 years;
- Central nervous system involvement (meningeal or parenchymal);
- Known hypersensitivity to any study drugs;
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 |
|---|---|---|
| Zeprumetostat( an EZH2 inhibitor) + XZeprumetostat( an EZH2 inhibitor) + JAK1 inhibitor or GemOx | Drug | Zeprumetostat + X |
Primary outcome
Summary of DLT events (Phase Ib)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
A Phase Ib Dose-Finding Study of Zeprumetostat in Combination Using a 3+3 Design
Overall response rate (Phase Ⅱ)
Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment EZH2+JAK1/GeMox
5 secondary outcomes
Complete response rate
Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Duration of response
Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Progression free survival
Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Overall survival
Time frame: Through study completion, an average of 3 years after EZH2+JAK1/GemOx (Day 1)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
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 24 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for PTCL-NOS
RecruitingPhase 1/2
AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.
Lymphoma, Non-Hodgkin Lymphoma
Active, not recruitingPhase 1/2
A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
Relapsed or Refractory T-cell Lymphomas
Active, not recruitingPhase 1
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
Relapsed or Refractory T Cell Lymphoma
RecruitingPhase 3
Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma
RecruitingPhase 3
Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy
Anaplastic Large Cell Lymphoma, ALK-Negative, Follicular Helper T-Cell Lymphoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zeprumetostat( an EZH2 inhibitor) + X in people with PTCL-NOS, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 9 inclusion and 16 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Zhang huilai, MD (+86-18622221228, huilaizhangtz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of DLT events (Phase Ib) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 2 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 24 Jul 2026.