PTCLPhase 2NCT07347288
SHR2554 as Maintenance Therapy in Patients With Peripheral T-cell Lymphoma
A Phase 2 study testing SHR2554 Tablets in people with PTCL, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Evaluation of the Safety and Efficacy of SHR2554 as Maintenance Therapy after first-line systemic treatment in patients with peripheral T-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTCL
- What is being tested?
- SHR2554 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Jun 2029
- Phase
- Phase 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 old
- Histologically confirmed PTCL,including PTCL NOS, ALCL, nTFHL,MEITL,ENKTL etc. according to WHO 2022 criteria.
- Previously received first-line systemic induction therapy and achieved CR/PR; Auto-transplantation or allo-transplantation are allowed.
- A measurable or evaluable disease at the time of first diagnosis of PTCL (any nodes/nodal masses>1.5 cm in longest diameter (LDi) or extralymphatic sites of disease >1.0 cm in LDi)
- ECOG PS 0-2
- With adequate organ function
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- Expected survival ≥ 12 weeks
- Women of childbearing potential (WOCBP) should be proven to be negative by human chorionic gonadotropin (hCG) test in 7 days before the first dose of SHR2554. They must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from the day they sign the informed consent form (ICF) to at least 30 days after receiving the last dose of study treatment. Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy；
- Participant who has provided written consent to participate in the study and ability to comply with all aspects of the protocol.
Who cannot join
- cutaneous T cell lymphoma
- Has a prior malignancy other than the malignancies under study within 3 years without relieve
- Participants with a presence of central nerves invasion
- Known sensitivity or allergy to investigational product
- Participated in another clinical trial within 4 weeks prior to the start of the study;
- Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
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- Active infected persons, except tumor-related B symptom fever;
- Diseases and medical history:
- 1.have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 2.have a history of psychotropic substance abuse and can not quit or have mental disorders; 3.Subjects with any severe and/or uncontrolled medical condition; 9.A history of immunodeficiency 10.Patients with mental disorders or those unable to provide informed consent 11.In any conditions which investigator considered ineligible for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
About this study
Official title: An Open-label, Multicenter Exploratory Clinical Study of the EZH2 Inhibitor SHR2554 as Maintenance Therapy After First-line Systemic Treatment in Patients With Peripheral T-cell Lymphoma
Evaluation of the Safety and Efficacy of SHR2554 as Maintenance Therapy after first-line systemic treatment in patients with peripheral T-cell lymphoma
- Conditions
- PTCL
- Being tested
- SHR2554 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2554 TabletsDrug
SHR2554 orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| SHR2554 monotherapy | Experimental | Patients With Peripheral T-cell Lymphoma After First-line Systemic Treatment Receiving SHR2554 monotherapy as Maintenance Therapy Receives: Drug: SHR2554 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 years PFS
The 2-year rate of during and after treatment that the participant lives without progression of the disease, as assessed by 2014 Lugano criteria.
Measured: 2 years
Secondary outcomes (7)
1-year and 2-year DFS rates for patients who were in CR at enrollment
The rate of 1-year and 2-year that the participant lives without disease, as assessed by 2014 Lugano criteria.
Measured: 1year,2year
Rate of patients who were PR at enrollment converting to CR
The Rate of patients who were PR at enrollment converting to CR
Measured: Time from the first dose to any events, assessed up to 12 months
Complete Response Rate (CR)
The proportion of participants who achieve a complete response (CR) during the treatment period, as assessed by the 2014 Lugano criteria using FDG-PET imaging.
Measured: Time from the first dose to disease progression or death, assessed up to 12months
Duration of Response (DoR)
The interval from the initial documentation of response (CR or PR) to the first documentation of disease progression or death.
Measured: From the date response is first documented to the date of disease progression or death, up to 36 months
Progression-Free Survival (PFS)
The length of time during and after treatment that the participant lives without progression of the disease, as assessed by 2014 Lugano criteria.
Measured: Time from the first dose to disease progression or death, assessed up to 36 months
Overall Survival (OS)
The length of time from the start of treatment until death from any cause.
Measured: Time from the first dose to death from any cause, assessed up to 36 months
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
The incidence, type, and severity of adverse events (graded according to CTCAE v5.0), and their relationship to the study treatment.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCLStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347288
- Sponsor's protocol ID
- 2025-SR-1121
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 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 SHR2554 as Maintenance Therapy After First-line Systemic Treatment in Patients With Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07347288
- Acronym / sponsor ID
- 2025-SR-1121
- Conditions
- PTCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 16 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.
Evaluation of the Safety and Efficacy of SHR2554 as Maintenance Therapy after first-line systemic treatment in patients with peripheral T-cell lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR2554 monotherapy | Experimental | Drug: SHR2554 TabletsPatients With Peripheral T-cell Lymphoma After First-line Systemic Treatment Receiving SHR2554 monotherapy as Maintenance Therapy |
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 old
- Histologically confirmed PTCL,including PTCL NOS, ALCL, nTFHL,MEITL,ENKTL etc. according to WHO 2022 criteria.
- Previously received first-line systemic induction therapy and achieved CR/PR; Auto-transplantation or allo-transplantation are allowed.
- A measurable or evaluable disease at the time of first diagnosis of PTCL (any nodes/nodal masses>1.5 cm in longest diameter (LDi) or extralymphatic sites of disease >1.0 cm in LDi)
- ECOG PS 0-2
Key exclusion criteria (9 listed)
- cutaneous T cell lymphoma
- Has a prior malignancy other than the malignancies under study within 3 years without relieve
- Participants with a presence of central nerves invasion
- Known sensitivity or allergy to investigational product
- Participated in another clinical trial within 4 weeks prior to the start of the study;
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 |
|---|---|---|
| SHR2554 TabletsSHR2554 orally twice daily | Drug | SHR2554 monotherapy |
Primary outcome
2 years PFS
Time frame: 2 years
The 2-year rate of during and after treatment that the participant lives without progression of the disease, as assessed by 2014 Lugano criteria.
7 secondary outcomes
1-year and 2-year DFS rates for patients who were in CR at enrollment
Time frame: 1year,2year
Rate of patients who were PR at enrollment converting to CR
Time frame: Time from the first dose to any events, assessed up to 12 months
Complete Response Rate (CR)
Time frame: Time from the first dose to disease progression or death, assessed up to 12months
Duration of Response (DoR)
Time frame: From the date response is first documented to the date of disease progression or death, up to 36 months
Progression-Free Survival (PFS)
Time frame: Time from the first dose to disease progression or death, assessed up to 36 months
Overall Survival (OS)
Time frame: Time from the first dose to death from any cause, assessed up to 36 months
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
Time frame: Up to 12 months
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 16 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR2554 Tablets in people with PTCL, run by The First Affiliated Hospital with Nanjing Medical University 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 9 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 16 Jan 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 phase mean?
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 Wei Xu, Doctor (86-2568302182, xuwei10000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 years PFS (time frame: 2 years). 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 16 Jan 2026.