Relapsed/Refractory Peripheral T Cell LymphomaPhase 2NCT06519526
Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
A Phase 2 study testing SHR-0302 and SHR-2554 in people with Relapsed/Refractory Peripheral T Cell Lymphoma, run by Fudan University at 1 site in China.
Trial summary
This is an open-label, prospective and exploratory clinical study to evaluate the efficacy and safety of JAK inhibitor SHR-0302 in combination with EZH2 inhibitor SHR-2554 in patients with R/R PTCL. The study plans to enroll approximately 25 patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed/Refractory Peripheral T Cell Lymphoma
- What is being tested?
- SHR-0302 and SHR-2554
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2024to 31 Aug 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18-70 years (inclusive);
- Histologically confirmed peripheral T-cell lymphoma;
- Disease status defined as relapsed or refractory after >=1 prior systemic treatment lines;
- Have measurable lesions;
- ECOG performance status must be 0 or 1 and has not deteriorated in the past 2 weeks;
- Life expectancy ≥12 weeks;
- Adequate bone marrow reserve and organ system function reserve;
- Participants should be able and willing to comply with the study protocol requirement;
Who cannot join
- Received anti-tumor treatment within 28 days prior to the first dose of the study drug; received Chinese medicine treatment with anti-tumor effect within 14 days before the first dose of the study drug; received steroid hormones within 7 days prior to the first dose of study drug administration;
- Underwent major surgery within 4 weeks prior to the first dose of study treatment；
- Severe cardiovascular disease;
- Cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment;
- Significant impairment of lung function;
- Active infections;
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- Unexplained fever > 38.5°C during screening period or on the first day of medication;
- Pregnant;
- Known alcohol or drug abuse;
- Subjects are currently receiving known moderately potent or potent CYP inducers/inhibitors or P-glycoprotein (P-gp) inhibitors;
- History of hypersensitivity to the investigational drug or its excipients;
- In the judgment of the investigator, objective conditions make the subject unable to complete the planned study or the subject has other factors, concomitant diseases, combined treatment or abnormal laboratory examination that may lead to the forced termination of the 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, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Rong Tao, MD, 8621-64175590, rtao@shca.org.cn
Chuanxu Liu, MD, 8621-64175590, liuchuanxu@shca.org.cn
About this study
This is an open-label, prospective and exploratory clinical study to evaluate the efficacy and safety of JAK inhibitor SHR-0302 in combination with EZH2 inhibitor SHR-2554 in patients with R/R PTCL. The study plans to enroll approximately 25 patients. 6-12 patients will receive SHR-0302 monotherapy and SHR-0302+SHR-2554 combination therapy in the safety run-in phase. According to the safety observed, the investigators discuss and decide to select a dose group to explore the efficacy and safety. 13 patients may be enrolled in the expansion phase.
Read the detailed description
This is an open-label, prospective, exploratory clinical study. The plan is to enroll 12-25 patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) to receive a combination of SHR-0302 and SHR-2554. The primary objectives are to evaluate the efficacy and safety of the SHR-0302 and SHR-2554 combination in the treatment of r/r PTCL. Subjects will receive the investigating drugs combination (SHR-0302 and SHR-2554) until study completion, unacceptable toxicity, disease progression, withdrawal of informed consent, or investigators discontinue treatment.
The study is divided into two parts. Part I is a safety run-in phase, and part II is an efficacy exploration phase.
Part I:
Cohort 1: Explore the recommended dose and safety of SHR-0302 monotherapy Cohort 2: Based on the efficacy and safety observed in Cohort 1, explore the clinically recommended dose and safety of the SHR-0302 and SHR-2554.
Part II: Based on the safety and tolerability observed during part I, the investigators will discuss and select one tolerable dose cohort to explore the efficacy and safety.
- Being tested
- SHR-0302, SHR-2554
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-0302Drug
SHR-0302 will be administered orally as tablets.
SHR-2554Drug
SHR-2554 will be administered orally as tablets.
| Study group | Role | What they receive |
|---|---|---|
| SHR-0302 and SHR-2554 Treatment Arm | Experimental | SHR-2554 Oral administration, twice daily, with a 28-day continuous dosing as one cycle. SHR-0302: Oral administration, once daily, Receives: Drug: SHR-0302; Drug: SHR-2554 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs and SAEs
Incidence and severity of AEs and SAEs will be recorded and graded according to the CTCAE 5.0.
Measured: The first dose until 30 days after last dose
Objective response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR) according to Lugano 2014 criteria.
Measured: 24 months
Secondary outcomes (4)
Disease Control Rate (DCR)
Percentage of patients achieving complete response (CR) and partial response (PR) and stable disease (SD) according to Lugano 2014 criteria.
Measured: 24 months
Duration of Response (DoR)
Defined as the time from the date of the first CR or PR to the date of the first PD or death due to any cause, whichever occurs first.
Measured: 24 months
Progression-free Survival (PFS)
Defined as the time from the date of the first dose to the first documented PD or death due to any cause, whichever occurs first.
Measured: 24 months
Overall Survival (OS)
Defined as the duration of time from start of treatment to death from any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start12 Aug 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Tao, Fudan University
- Investigators
- Rong Tao, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519526
- Sponsor's protocol ID
- PTCL-IIT-SHR2554-SHR0302
- Status last verified
- Mar 2026
- First submitted
- 19 Jul 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06519526
- Acronym / sponsor ID
- PTCL-IIT-SHR2554-SHR0302
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 25 Jul 2024 (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 an open-label, prospective and exploratory clinical study to evaluate the efficacy and safety of JAK inhibitor SHR-0302 in combination with EZH2 inhibitor SHR-2554 in patients with R/R PTCL. The study plans to enroll approximately 25 patients. 6-12 patients will receive SHR-0302 monotherapy and SHR-0302+SHR-2554 combination therapy in the safety run-in phase. According to the safety observed, the investigators discuss and decide to select a dose group to explore the efficacy and safety. 13 patients may be enrolled in the expansion phase.
Detailed description
This is an open-label, prospective, exploratory clinical study. The plan is to enroll 12-25 patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) to receive a combination of SHR-0302 and SHR-2554. The primary objectives are to evaluate the efficacy and safety of the SHR-0302 and SHR-2554 combination in the treatment of r/r PTCL. Subjects will receive the investigating drugs combination (SHR-0302 and SHR-2554) until study completion, unacceptable toxicity, disease progression, withdrawal of informed consent, or investigators discontinue treatment.
The study is divided into two parts. Part I is a safety run-in phase, and part II is an efficacy exploration phase.
Part I:
Cohort 1: Explore the recommended dose and safety of SHR-0302 monotherapy Cohort 2: Based on the efficacy and safety observed in Cohort 1, explore the clinically recommended dose and safety of the SHR-0302 and SHR-2554.
Part II: Based on the safety and tolerability observed during part I, the investigators will discuss and select one tolerable dose cohort to explore the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-0302 and SHR-2554 Treatment Arm | Experimental | Drug: SHR-0302, Drug: SHR-2554SHR-2554 Oral administration, twice daily, with a 28-day continuous dosing as one cycle. SHR-0302: Oral administration, once daily, |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females aged 18-70 years (inclusive);
- Histologically confirmed peripheral T-cell lymphoma;
- Disease status defined as relapsed or refractory after >=1 prior systemic treatment lines;
- Have measurable lesions;
- ECOG performance status must be 0 or 1 and has not deteriorated in the past 2 weeks;
Key exclusion criteria (12 listed)
- Received anti-tumor treatment within 28 days prior to the first dose of the study drug; received Chinese medicine treatment with anti-tumor effect within 14 days before the first dose of the study drug; received steroid hormones within 7 days prior to the first dose of study drug administration;
- Underwent major surgery within 4 weeks prior to the first dose of study treatment；
- Severe cardiovascular disease;
- Cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment;
- Significant impairment of lung function;
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 |
|---|---|---|
| SHR-0302SHR-0302 will be administered orally as tablets. | Drug | SHR-0302 and SHR-2554 Treatment Arm |
| SHR-2554SHR-2554 will be administered orally as tablets. | Drug | SHR-0302 and SHR-2554 Treatment Arm |
Primary outcome
Incidence and severity of AEs and SAEs
Time frame: The first dose until 30 days after last dose
Incidence and severity of AEs and SAEs will be recorded and graded according to the CTCAE 5.0.
Objective response rate (ORR)
Time frame: 24 months
Percentage of participants achieving complete response (CR) and partial response (PR) according to Lugano 2014 criteria.
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: 24 months
Duration of Response (DoR)
Time frame: 24 months
Progression-free Survival (PFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 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 24 Mar 2026.
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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.
Rong Tao, MD principal investigator
Fudan University
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 SHR-0302 and SHR-2554 in people with Relapsed/Refractory Peripheral T Cell Lymphoma, run by Fudan 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 8 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: looking for participants now, as of the sponsor's last update on 24 Mar 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 Rong Tao, MD (8621-64175590, rtao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs and SAEs (time frame: The first dose until 30 days after last dose). 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 Mar 2026.