PTCLPhase 1/2NCT07725705
SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL)
A Phase 1/2 study testing SHR2554 combined with Liposomal Mitoxantrone in people with PTCL and First Line Treatment, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This is a single-arm, multicenter, Phase Ib/IIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PTCL, First Line Treatment
- What is being tested?
- SHR2554 combined with Liposomal Mitoxantrone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old,regardless of gender;
- Centrally confirmed histopathological/cytologic diagnosis of PTCL with the following subtypes:Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS; Enteropathy-associated T-cell lymphoma(EATL); Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.
- No prior anti-tumor therapy.
- There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma: Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET/CT or Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions >1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma;
- ECOG performance status score: 0-2;
- Expected survival time ≥3 months;
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- Have adequate organ and bone marrow functiont;
- No concurrent hemophagocytic lymphohistiocytosis (HLH). If a patient has clinically diagnosed HLH, enrollment eligibility will be determined by the investigator based on an evaluation of the patient's general physical condition following targeted anti-HLH therapy.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of medication; Effective contraception should be used from the time of informed consent until 6 months after the last dose of study drug.
- Capable of understanding the study procedures and voluntarily signing a written informed consent form (ICF).;
Who cannot join
- Prior treatment with epigenetic agents before enrollment;
- Patients with a history of severe cardiac disease, history of radiation therapy to the mediastinal/pericardial region, cumulative anthracycline dose > 550 mg (doxorubicin equivalent), prior use of mitoxantrone, baseline left ventricular ejection fraction (LVEF) < 50%, or history of exposure to other cardiotoxic drugs;
- History of other primary aggressive malignancies that are not in remission, or have been in remission for less than 3 years;
- Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
- Known allergy or hypersensitivity to the study drugs or their related metabolites;
- Currently participating in another clinical study, or less than 4 weeks elapsed from the end of treatment in a previous clinical study to the planned start of study treatment;
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- Pregnant or lactating women;
- Active infections;
- Medical History and Concurrent Conditions;
- 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;
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, Phase Ib/II Exploratory Clinical Study of EZH2 Inhibitor SHR2554 in Combination With Liposomal Mitoxantrone for the First-line Treatment of Peripheral T-cell Lymphoma
This is a single-arm, multicenter, Phase Ib/IIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). The study is divided into a Phase Ib safety lead-in phase and a Phase IIa dose expansion phase.
- Conditions
- PTCL, First Line Treatment
- Being tested
- SHR2554 combined with Liposomal Mitoxantrone
- Keywords
- EZH2 inhibitor, SHR2554, Liposomal Mitoxantrone, First-line Treatment of PTCL, Zeprumetostat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2554 combined with Liposomal MitoxantroneDrug
Patients will receive 6 cycles of SHR2554 combined with liposomal mitoxantrone as induction therapy. All patients who achieve a complete response (CR) after induction therapy are eligible for transplantation. Patients achieving CR or partial response (PR), as well as those post-transplantation, may receive SHR2554 maintenance therapy in 28-day cycles. Maintenance therapy will continue until disease progression or other reasons for discontinuation. The maximum duration of SHR2554 administration in the maintenance phase will not exceed 24 months.
| Study group | Role | What they receive |
|---|---|---|
| SHR2554 combined with Liposomal Mitoxantrone | Experimental | Not described Receives: Drug: SHR2554 combined with Liposomal Mitoxantrone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLT)
Adverse events (AE) defined as DLT events per protocol
Measured: Cycle 1 (28 days)
Complete response (CR) rate
The proportion of subjects evaluated as complete response (CR) according to Lugano 2014 efficacy evaluation criteria
Measured: up to 6 months after enrollment
Secondary outcomes (6)
Objective response rate (ORR)
The proportion of subjects evaluated as complete response (CR) and partial response (PR) according to Lugano 2014 efficacy evaluation criteria
Measured: up to 6 months after enrollment
Duration of Response (DOR)
The time from the first assessment of CR/PR to the first assessment of PD or death from any cause in the subject
Measured: up to 2.5 years post first treatment
Duration of complete response (CR)
The time from the first assessment of CR to the first assessment of PD or death from any cause in the subject
Measured: up to 2.5 years post first treatment
Progression-free Survival (PFS)
From the time subjects were enrolled to the time of disease progression (in any way) or death from any cause.
Measured: Up to 2.5 years
Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause.
Measured: Up to 2.5 years
Adverse events(AE)
The safety of the drug was evaluated by NCI-CTC AE 6.0 standard. Hematologic and non-hematologic toxicity.
Measured: From the first day of medication to 28 days after the last dose
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 completion1 Aug 2028 (estimated)
- Study completion1 Mar 2030 (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 Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725705
- Sponsor's protocol ID
- IIT2026083
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
- An Open-label, Multicenter, Phase Ib/II Exploratory Clinical Study of EZH2 Inhibitor SHR2554 in Combination With Liposomal Mitoxantrone for the First-line Treatment of Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07725705
- Acronym / sponsor ID
- IIT2026083
- Conditions
- PTCL, First Line Treatment
- Keywords
- EZH2 inhibitor, SHR2554, Liposomal Mitoxantrone, First-line Treatment of PTCL, Zeprumetostat
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Mar 2030 (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, multicenter, Phase Ib/IIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). The study is divided into a Phase Ib safety lead-in phase and a Phase IIa dose expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR2554 combined with Liposomal Mitoxantrone | Experimental | Drug: SHR2554 combined with Liposomal Mitoxantrone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years old,regardless of gender;
- Centrally confirmed histopathological/cytologic diagnosis of PTCL with the following subtypes:Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS; Enteropathy-associated T-cell lymphoma(EATL); Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.
- No prior anti-tumor therapy.
- There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma: Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET/CT or Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions >1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma;
- ECOG performance status score: 0-2;
Key exclusion criteria (12 listed)
- Prior treatment with epigenetic agents before enrollment;
- Patients with a history of severe cardiac disease, history of radiation therapy to the mediastinal/pericardial region, cumulative anthracycline dose > 550 mg (doxorubicin equivalent), prior use of mitoxantrone, baseline left ventricular ejection fraction (LVEF) < 50%, or history of exposure to other cardiotoxic drugs;
- History of other primary aggressive malignancies that are not in remission, or have been in remission for less than 3 years;
- Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
- Known allergy or hypersensitivity to the study drugs or their related metabolites;
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 combined with Liposomal MitoxantronePatients will receive 6 cycles of SHR2554 combined with liposomal mitoxantrone as induction therapy. All patients who achieve a complete response (CR) after induction therapy are eligible for transplantation. Patients achieving CR or partial response (PR), as well as those post-transplantation, may receive SHR2554 maintenance therapy in 28-day cycles. Maintenance therapy will continue until disease progression or other reasons for discontinuation. The maximum duration of SHR2554 administration in the maintenance phase will not exceed 24 months. | Drug | SHR2554 combined with Liposomal Mitoxantrone |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLT)
Time frame: Cycle 1 (28 days)
Adverse events (AE) defined as DLT events per protocol
Complete response (CR) rate
Time frame: up to 6 months after enrollment
The proportion of subjects evaluated as complete response (CR) according to Lugano 2014 efficacy evaluation criteria
6 secondary outcomes
Objective response rate (ORR)
Time frame: up to 6 months after enrollment
Duration of Response (DOR)
Time frame: up to 2.5 years post first treatment
Duration of complete response (CR)
Time frame: up to 2.5 years post first treatment
Progression-free Survival (PFS)
Time frame: Up to 2.5 years
Overall survival (OS)
Time frame: Up to 2.5 years
Adverse events(AE)
Time frame: From the first day of medication to 28 days after the last dose
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
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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 SHR2554 combined with Liposomal Mitoxantrone in people with PTCL and First Line Treatment, run by Institute of Hematology & Blood Diseases Hospital, 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 10 inclusion and 12 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.
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 Liang Huang (+86 022-23608126, huangliang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLT) (time frame: Cycle 1 (28 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.