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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (NCT06776952) is a Phase 3 interventional studying Relapsed/Refractory Peripheral T Cell Lymphoma, sponsored by Evopoint Biosciences Inc.. 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 is a randomized, double-blind, multi-center, phase III clinical trial designed to evaluate the efficacy of XNW5004 tablets versus Chidamide in Relapsed/Refractory PTCL, with a target of enrolling 120 subjects.

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 Peripheral T Cell Lymphoma, 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 120 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 Peripheral T Cell Lymphoma 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: - Aged 18-70 years (inclusive),gender not limited. - Pathologically diagnosed, relapsed or refractory peripheral T-cell lymphoma. - Disease status defined as relapsed or refractory after \>=1 prior systemic treatment lines, and have not received treatment with HDAC inhibitors, subjects with NK/T-cell lymphoma require treatment with a regimen containing asparaginase/protease, subjects with CD30 positive ALCL require prior treatment with Brentuximab vedotin. - Subjects who have received prior radiotherapy are allowed to enroll, but radiotherapy alone is not considered a systemic therapy. - Having at least one measurable lesion for evaluation. - Agree to provide archived tumor tissue samples or fresh tumor tissue samples that meet the requirements. - expected to live at least 12 weeks. - Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. - Have your organs (liver, kidneys, etc.) are working well enough based on blood tests. - Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized. For male subjects whose partner is a woman of childbearing potential, surgical sterilization or agreement to use effective contraception for the duration of the study and for 6 months after the last dose of study drug is required. In addition, males must agree not to donate sperm during the study participation and for at least 6 months after the last dose of study drug. - Able to provide written willing to sign a consent form form prior to the commencement of any study activity/procedure. Who Should NOT Join This Trial: ...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: * Aged 18-70 years (inclusive),gender not limited. * Pathologically diagnosed, relapsed or refractory peripheral T-cell lymphoma. * Disease status defined as relapsed or refractory after \>=1 prior systemic treatment lines, and have not received treatment with HDAC inhibitors, subjects with NK/T-cell lymphoma require treatment with a regimen containing asparaginase/protease, subjects with CD30 positive ALCL require prior treatment with Brentuximab vedotin. * Subjects who have received prior radiotherapy are allowed to enroll, but radiotherapy alone is not considered a systemic therapy. * Having at least one measurable lesion for evaluation. * Agree to provide archived tumor tissue samples or fresh tumor tissue samples that meet the requirements. * Life expectancy of at least 12 weeks. * Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Have adequate organ function. * Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized. For male subjects whose partner is a woman of childbearing potential, surgical sterilization or agreement to use effective contraception for the duration of the study and for 6 months after the last dose of study drug is required. In addition, males must agree not to donate sperm during the study participation and for at least 6 months after the last dose of study drug. * Able to provide written informed consent form prior to the commencement of any study activity/procedure. Exclusion Criteria: * Prior exposure to EZH2 inhibitor(s) or EZH1/2 inhibitor(s). * Prior exposure to HDAC inhibitor(s). * Subjects with known hypersensitivity to the study drug or its active ingredients or excipients. * Subjects who have received anti-tumor therapy, such as chemotherapy, immunotherapy, radiotherapy, and targeted therapy, within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, received CAR-T therapy within 12 weeks prior to the first dose of the study drug, autologous hematopoietic stem cell transplantation (Auto-HSCT) within 3 months prior to the first dose of the study drug. * Subjects who have received other anti-tumor investigational drug treatment within 28 days prior to the first dose of XNW5004 in this study. * Subjects who have undergone major surgery within 4 weeks prior to the start of study treatment or who intend to undergo major surgery during this study (except for procedures such as puncture or lymph node biopsy). * Subjects who have an allogeneic hematopoietic stem cell transplantation or solid organ transplantation. * Subjects who have received systemic treatment with corticosteroids (prednisone at a dose of \> 10 mg per day or equivalent doses of other glucocorticoids) or other immunosuppressive drugs within 14 days prior to the use of the study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with prednisone at a dose of ≤ 10 mg per day or equivalent doses of other glucocorticoids are permitted. * Subjects taking known strong CYP3A4 inhibitors/inducers and P-glycoprotein (P-gp) inhibitors within 14 days prior to the first dose. * Subjects who have received live virus vaccines (including live attenuated vaccines) within 28 days prior to dosing. Inactivated vaccines are permitted. * Subjects with a history of psychotropic drug abuse or drug abuse. * Subjects who have received anti-tumor therapy in the early stage and have not recovered from toxicity (toxicity has not recovered to ≤ Grade 1 according to NCI-CTCAE 5.0). Except for other toxicities (such as alopecia, etc.) that do not affect the safety evaluation of subjects in the opinion of the investigator. * Subjects with history of other malignancies within 3 years prior to enrollment and not meeting clinical cure criteria. Exceptions are the following: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid that can be treated locally. * Subjects with mycosis fungoides, Sézary syndrome, or primary cutaneous T-cell lymphoma. * Subjects with previous or current central nervous system invasion. * Subjects with previous or current testicular or breast invasion. * Subjects with previous or current hemophagocytic syndrome. * Subjects with previous or current primary or secondary hematologic diseases that may affect bone marrow function in addition to primary malignancies, such as immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, etc. * Subjects with previous or current acute myeloid leukemia (AML). * Subjects with previous or current T-cell lymphoblastic lymphoma (T-LBL) or T-lymphoblastic leukemia. * Subjects who have any history of myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal tests results of markers related to MDS or myeloproliferative neoplasm (MPN). * Subjects who previously hadcentral nervous system lesions, or diseases accompanies with central nervous system lesions, including but not limited to, epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, cerebral organic syndrome, or psychosis, etc. * Subjects with clinically significant cardiovascular disease. * Tumor invasion of important peripheral organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) posing a risk of bleeding or the risk of esophageal tracheal fistula or esophageal pleural fistula. * Subjects with clinically symptomatic thoracoabdominal effusion or pericardial effusion that are poorly controlled after repeated treatment. * Subjects with unexplained fever and body temperature\>38.0 ℃. * Subjects who have severe active systemic infection. * Subjects with a history of tuberculosis infection within one year prior to enrollment, or with a history of active tuberculosis infection more than one year ago without sufficient anti tuberculosis treatment. * A known history of HIV infection or acquired immunodeficiency syndrome (AIDS), or Anti- Treponema Pallidum test (anti-TP) positive. * Subjects who have HBV-DNA copy numbers higher than the lower normal limit of the detection value. Subjects with HCV-RNA copy number higher than the lower normal limit of the detection value. * Subjects who are unable to swallow or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or has undergone gastrectomy or gastric banding that affects drug absorption. But gastroesophageal reflux that has been treated with proton pump inhibitors is allowed (if there is no possibility of drug interaction). * Subjects with conditions known to have bleeding tendencies, such as von Willebrand disease or hemophilia. * Subjects who are pregnant or breastfeeding, or expects to conceive within the projected duration of the study. * Subject who may not be able to complete this study for other reasons or who, in the opinion of the investigator, should not participate the study.

Treatments Being Tested

DRUG

XNW5004 ; Chidamide placebo

XNW5004 + Chidamide placebo

DRUG

XNW5004 placebo; Chidamide

XNW5004 placebo + 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.

Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06776952), the sponsor (Evopoint Biosciences Inc.), 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 NCT06776952 clinical trial studying?

This is a randomized, double-blind, multi-center, phase III clinical trial designed to evaluate the efficacy of XNW5004 tablets versus Chidamide in Relapsed/Refractory PTCL, with a target of enrolling 120 subjects. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06776952?

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 NCT06776952?

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 NCT06776952. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06776952. 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 2026-05-08 · Data from ClinicalTrials.gov.