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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

SHR2554 Clinical Study of Chidamide in the Treatment of T-cell Lymphoma

A Double-blinded, Randomized, Multi-center Phase III Clinical Study of SHR2554 Versus Chidamide in Patients With Relapsed/Refractory PTCL

SHR2554 Clinical Study of Chidamide in the Treatment of T-cell Lymphoma (NCT06122389) is a Phase 3 interventional studying Relapsed/Refractory PTCLT With at Least One Line of Prior Systemic Therapy, sponsored by Jiangsu HengRui Medicine Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study was designed to compare the efficacy and safety of SHR2554 with Chidamide in patients with relapsed/refractory PTCL.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Relapsed/Refractory PTCLT With at Least One Line of Prior Systemic Therapy, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 130 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Relapsed/Refractory PTCLT With at Least One Line of Prior Systemic Therapy subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18-70 years old (including 18 and 70 years old), gender is not limited; 2. diagnosed by tissue sample (biopsy-confirmed) T-cell lymphoma; 3. ECOG physical status must be 0 or 1; 4. Life expectancy ≥12 weeks; 5. For relapsed refractory patients who have received ≥ first-line treatment, at least one prior treatment is adequate; 6. Have not received histone deacetylase inhibitors; 7. Have measurable lesions; 8. Bone marrow function is basically normal; 9. Liver and kidney function is basically normal; 10. Blood coagulation function is basically normal; 11. Female subjects with a possibility of becoming pregnant must undergo a blood pregnancy test prior to the first dose, with a negative result, and be willing to use a highly effective method of contraception for 90 days after signing the notification until the last dose of the study drug. Male subjects whose partners are women at risk of becoming pregnant should be surgically sterilized or agree to use highly effective methods of contraception for 90 days from the date of signing the notification until the last administration of the study drug; 12. The subject has recovered from the toxic effects of the last treatment before the first dosing; 13. The subject personally signs and dates the willing to sign a consent form to show that the subject has been fully informed of all the circumstances related to the clinical trial; 14. Subjects are willing and able to comply with visit schedules, dosing schedules, laboratory examinations, and other clinical trial procedures. Who Should NOT Join This Trial: 1. Have been treated with compounds with the same mechanism; 2. Accompanied by central nervous system infiltration; 3. Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation within 90 days; 4. Major surgery or severe trauma occurred 4 weeks before the first dose of study drug administration; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age 18-70 years old (including 18 and 70 years old), gender is not limited; 2. Histologically confirmed T-cell lymphoma; 3. ECOG physical status must be 0 or 1; 4. Life expectancy ≥12 weeks; 5. For relapsed refractory patients who have received ≥ first-line treatment, at least one prior treatment is adequate; 6. Have not received histone deacetylase inhibitors; 7. Have measurable lesions; 8. Bone marrow function is basically normal; 9. Liver and kidney function is basically normal; 10. Blood coagulation function is basically normal; 11. Female subjects with a possibility of becoming pregnant must undergo a blood pregnancy test prior to the first dose, with a negative result, and be willing to use a highly effective method of contraception for 90 days after signing the notification until the last dose of the study drug. Male subjects whose partners are women at risk of becoming pregnant should be surgically sterilized or agree to use highly effective methods of contraception for 90 days from the date of signing the notification until the last administration of the study drug; 12. The subject has recovered from the toxic effects of the last treatment before the first dosing; 13. The subject personally signs and dates the informed consent to show that the subject has been fully informed of all the circumstances related to the clinical trial; 14. Subjects are willing and able to comply with visit schedules, dosing schedules, laboratory examinations, and other clinical trial procedures. Exclusion Criteria: 1. Have been treated with compounds with the same mechanism; 2. Accompanied by central nervous system infiltration; 3. Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation within 90 days; 4. Major surgery or severe trauma occurred 4 weeks before the first dose of study drug administration; 5. Received anti-tumor treatment within 4 weeks before the first dose of the study drug, and received Chinese medicine treatment with anti-tumor effect within 2 weeks before the first dose of the study drug; Receiving steroid hormones within 7 days prior to the first dose of study drug administration; 6. Active phase of HBV or HCV infection; 7. A history of immunodeficiency, including HIV seropositive, or other acquired or congenital immunodeficiency diseases; 8. Active infection or unexplained fever \> 38.5°C within 2 weeks of initial dosing; 9. A history of clinically severe cardiovascular disease; 10. Abnormal electrocardiogram (ECG) examination; 11. Cerebrovascular accident or transient ischemic attack occurred within 6 months before entering the study; 12. Have other malignancies within 5 years prior to screening, other than adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery (allowing hormone therapy for non-metastatic prostate cancer or breast cancer), and papillary thyroid cancer; 13. The subject has another serious/severe acute or chronic illness or mental illness, including recent (within the past year) or current suicidal ideation or behavior, or laboratory abnormalities that may increase the risks associated with participation in the study or administration of the investigational drug, may interfere with the interpretation of the study results, or may interfere with the investigator's judgment; 14. The subjects are the staff of the research center directly related to this clinical trial or their family members, or the subordinates of this trial although not directly related to this trial, or the staff employed by the sponsor directly related to this trial; 15. Pregnant and lactating women; 16. The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of gastrectomy or gastric banding that affects drug absorption; 17. The subject is taking a known medium or strong CYP inducer; 18. In the judgment of the investigator, objective conditions (including the subject's psychological state, family relationship, social factors or geographical factors) 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.

Treatments Being Tested

DRUG

SHR2554; Chidamide analog tablets

SHR2554 + Chidamide analog tablets

DRUG

SHR2554 analog tablets; Chidamide

SHR2554 analog tablets + Chidamide

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University Cancer Hospital
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06122389), the sponsor (Jiangsu HengRui Medicine Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06122389 clinical trial studying?

This study was designed to compare the efficacy and safety of SHR2554 with Chidamide in patients with relapsed/refractory PTCL. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06122389?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06122389?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06122389. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06122389. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.