Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 75

XNW5004 with CHOP/CHOEP in Untreated Peripheral T-Cell Lymphoma

Official title: A Phase Ib/II Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma

Run by Evopoint Biosciences Inc. · NCT07730515 · Data updated 2026-11-12

This study tests XNW5004 together with CHOP or CHOEP in adults with newly diagnosed peripheral T-cell lymphoma to see if the combination is safe and active.

More Non-Hodgkin Lymphoma trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment176 (estimated)
SponsorEvopoint Biosciences Inc.
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, prednisone
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedAugust 15, 2025
Main results expectedSeptember 30, 2028
Study endsSeptember 30, 2028
Registry record updatedJuly 29, 2026
Trial IDNCT07730515 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–75 with pathologically confirmed newly diagnosed peripheral T-cell lymphoma, no prior systemic PTCL therapy, measurable disease, and adequate organ function.

Probably not a fit

Patients with poor organ reserve, unfavorable biomarker status, or intolerance to combined therapy may derive no benefit and could experience treatment-related toxicity.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study combines the EZH2 inhibitor XNW5004 with standard chemotherapy (CHOP or CHOEP) for patients with newly diagnosed peripheral T-cell lymphoma. It spans Phase 1 and Phase 2 to evaluate safety, tolerability, and preliminary efficacy, with incremental and extended dosing or scheduling options. Eligible participants are adults 18 to 75 with confirmed PTCL, measurable disease, adequate organ function, and good performance status who have not received prior systemic PTCL therapy. The study is led by Evopoint Biosciences Inc. and conducted at Shanghai Cancer Center in Shanghai, China.

Why it matters

Potential benefit: If successful, participants may experience improved disease control with a potential for longer remission when XNW5004 is added to standard chemotherapy.

How similar studies have gone: Previous studies using targeted agents with standard chemotherapy have shown mixed results; this trial explores a novel combination approach in PTCL.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 18 to 75 years (inclusive); both genders are eligible.
* Pathologically confirmed peripheral T-cell lymphoma (PTCL).
* No prior systemic anti-PTCL therapy.
* At least one measurable lesion as the basis for evaluation: nodal lesions with a long diameter \> 1.5 cm; extranodal lesions with a long diameter \> 1.0 cm.
* Life expectancy of at least 12 weeks.
* ECOG performance status score of 0-1.
* Vital organ function reserves meet the following requirements:
* Hematopoietic function:
* White blood cell count \>= 3.5 x 10\^9/L (no G-CSF administration within 1 week before the screening blood test, and no long-acting leukocyte-elevating agent administration within 2 weeks)
* Platelet count \>= 75 x 10\^9/L (no platelet transfusion or TPO receptor agonist administration within 1 week before the screening blood test)
* Hemoglobin \>= 80 g/L (no red blood cell transfusion or EPO administration within 1 week before the screening blood test)
* Hepatic function: serum total bilirubin \<= 1.5 x ULN (\<= 3 x ULN for Gilbert's syndrome), and ALT and AST \<= 2.5 x ULN; for subjects with liver infiltration, ALT/AST \<= 5 x ULN; for subjects with liver and/or bone infiltration, alkaline phosphatase \<= 5 x ULN
* Renal function: serum creatinine \<= 1.5 x ULN or estimated creatinine clearance \>= 60 mL/min according to the Cockcroft-Gault formula
* Left ventricular ejection fraction (LVEF) \>= 50%
* International normalized ratio (INR) \<= 1.5 x ULN, or prothrombin time (PT) and activated partial thromboplastin time (APTT) \<= 1.5 x ULN
* Women of childbearing potential must have a negative serum pregnancy test before entering this study and agree to use effective contraception from the start of the study until at least 6 months after the last dose of the investigational drug. Female subjects who are not capable of childbearing must have been naturally amenorrheic for at least 12 months and be confirmed by a specialist physician as having no reproductive function based on female hormone testing; or have undergone bilateral oophorectomy, hysterectomy, or tubal ligation at least 6 weeks prior to screening. Male subjects must agree to use adequate contraceptive measures from the start of the study until at least 6 months after the last dose of the investigational drug, and must not donate sperm.
* Provide a signed and dated written informed consent form prior to undergoing study-specific procedures, and be able to comply with clinical visits and study-related procedures.

Exclusion Criteria:

* Prior treatment with any anti-tumor therapy, including but not limited to: chemotherapy, immunotherapy, radiotherapy, targeted therapy, anti-tumor traditional Chinese medicine, or anti-tumor investigational drugs.
* Subjects with known hypersensitivity to the investigational drug or its active ingredients or excipients.
* Subjects who have undergone major surgery within 4 weeks prior to the first dose of the investigational drug, or who plan to undergo major surgery during the study period (except for procedures such as puncture or lymph node biopsy).
* Prior or planned allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
* Receipt of steroid hormones for anti-tumor purposes (daily dose \> 20 mg prednisone or equivalent dose of other glucocorticoids) within 7 days prior to the first dose of the investigational drug; or diseases requiring systemic treatment with steroid hormones (daily dose \> 10 mg prednisone or equivalent dose of other glucocorticoids) or other immunosuppressive drugs within 14 days prior to the first dose of the investigational drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with a daily dose \<= 10 mg prednisone or equivalent dose of other glucocorticoids are permitted.
* Subjects who have taken known moderate or strong CYP3A4 inhibitors/inducers within 14 days prior to the first dose.
* Receipt of live virus vaccine (including attenuated live vaccine) within 28 days prior to dosing. Inactivated vaccines are permitted.
* History of psychotropic substance abuse or drug addiction.
* History of other malignancies within 3 years prior to enrollment that do not meet clinical cure criteria. The following are exceptions: basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and has been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
* Mycosis fungoides, Sezary syndrome, and primary cutaneous T-cell lymphoma.
* Presence of central nervous system involvement.
* Presence of testicular or breast involvement.
* Prior or current hemophagocytic syndrome.
* Prior or current immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, or other primary or secondary hematological diseases that may affect bone marrow function other than the primary malignancy.
* Prior or current acute myeloid leukemia (AML).
* Prior or current T-cell lymphoblastic lymphoma (T-LBL) or T-cell lymphoblastic leukemia (T-ALL).
* History of any myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal laboratory markers associated with MDS or myeloproliferative neoplasm (MPN).
* Prior or concomitant central nervous system disorders, including but not limited to: epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, etc.
* Impaired cardiac function or clinically significant cardiac disease, including any of the following:
* Acute myocardial infarction within 12 months prior to the first dose
* Unstable angina pectoris
* Congestive heart failure (New York Heart Association functional class III or IV)
* Uncorrected serious arrhythmia, hypertension \>= 150/100 mmHg
* Prolonged QTc interval (defined as \> 450 ms for males and \> 470 ms for females, by Fredericia's formula)
* Prior history of other major cardiovascular diseases (e.g., valve replacement, coronary artery bypass grafting, etc.)
* Tumor invasion of surrounding vital organs and blood vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) with risk of bleeding, or risk of tracheoesophageal fistula or esophagopleural fistula.
* Subjects with clinically symptomatic pleural effusion, ascites, or pericardial effusion that is poorly controlled despite repeated treatment.
* Active severe systemic infection: a washout period of at least 2 weeks is required after completion of antifungal therapy (whether administered intravenously or orally); a washout period of at least 1 week is required after completion of other intravenous anti-infective therapy; other oral anti-infective therapies must be discontinued before the first dose of the investigational drug.
* Active tuberculosis under treatment.
* HIV-positive or syphilis (Anti-TP) positive subjects (subjects with negative syphilis non-specific antibody test results and judged by the investigator to have been cured of syphilis are not excluded).
* HBsAg positive with HBV-DNA copy number above the lower limit of normal detection, or HBcAb positive with HBV-DNA copy number above the lower limit of normal detection; HCV antibody positive with HCV-RNA copy number above the lower limit of normal detection.
* Subjects who are unable to swallow, or have active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or a history of gastrectomy or gastric banding that may affect drug absorption. However, gastroesophageal reflux treated with proton pump inhibitors is permitted (if there is no potential for drug interaction).
* Known hemorrhagic diathesis such as von Willebrand disease or hemophilia.
* Females who are pregnant or breastfeeding.
* Subjects who may not be able to complete the study for other reasons or whom the investigator considers should not be enrolled.

Where it's running

  • Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.