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Non-hodgkin LymphomaPhase 1/2NCT07730515

Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma

A Phase 1/2 study testing XNW5004 combined with CHOP (incremental), XNW5004 combined with CHOEP (incremental) and XNW5004 combined with CHOP (extended) in people with Non-hodgkin Lymphoma and Peripheral T-cell Lymphoma, run by Evopoint Biosciences Inc. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

In this study, the XNW5004 tablets combined with CHOP/CHOEP will be used for the treatment of newly diagnosed PTCL patients. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
XNW5004 combined with CHOP (incremental), XNW5004 combined with CHOEP (incremental) and XNW5004 combined with CHOP (extended)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteChina
Study dates
15 Aug 2025to 30 Sep 2028
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Linlin.li Li contact

18678888561

linlin.li@evopointbio.com

China1 site, 1 recruiting

  • Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Rong.Tao Tao, +86 13651603661, hkutao@hotmail.com

    Recruiting

Other trials in China

About this study

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

In this study, the XNW5004 tablets combined with CHOP/CHOEP will be used for the treatment of newly diagnosed PTCL patients.

Being tested
XNW5004 combined with CHOP (incremental), XNW5004 combined with CHOEP (incremental), XNW5004 combined with CHOP (extended), XNW5004 combined with CHOEP (extended)
Keywords
EZH2 inhibitor, XNW5004
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XNW5004 combined with CHOP (incremental)Drug

    Also called cyclophosphamide, doxorubicin, vincristine, prednisone acetate tablet

    The XNW5004 protocol has preset four dosage groups: 400mg, 800mg, 1200mg and 1600mg, administered twice daily (BID). The CHOP regimen is administered at a fixed dose, for a total of 6 cycles. After completing the combined treatment and without disease progression, the subjects will continue to receive XNW5004 at 1200mg BID for maintenance therapy.

  • XNW5004 combined with CHOEP (incremental)Drug

    Also called XNW5004, cyclophosphamide, doxorubicin, vincristine

    It is expected to conduct dose escalation studies for XNW5004 in combination with CHOEP using 1-3 dose groups. The CHOEP regimen will be administered at a fixed dose for a total of 6 cycles. After completing the combined treatment and without disease progression, the subjects will continue to receive XNW5004 at 1200mg BID for maintenance therapy.

  • XNW5004 combined with CHOP (extended)Drug

    Also called XNW5004, cyclophosphamide, doxorubicin, vincristine

    Those who received the combination treatment of XNW5004 and CHOP, and who did not experience disease progression after the combined treatment, will continue to receive maintenance treatment with XNW5004 at a dose of 1200mg twice daily.

  • XNW5004 combined with CHOEP (extended)Drug

    Also called cyclophosphamide, doxorubicin, vincristine, prednisone acetate tablet

    Those who received the combination treatment of XNW5004 and CHOEP, and who did not experience disease progression after the combined treatment, will continue to receive maintenance treatment with XNW5004 at a dose of 1200mg twice daily.

Study groups in NCT07730515
Study groupRoleWhat they receive
Ib stage,Cohort1ExperimentalPhase of dose escalation for the XNW5004 tablet in combination with CHOP regimen.
Receives: Drug: XNW5004 combined with CHOP (incremental)
Ib stage,Cohort2ExperimentalPhase of dose escalation for the XNW5004 tablet in combination with CHOEP regimen
Receives: Drug: XNW5004 combined with CHOEP (incremental)
Phase II, dose expansion stage,CHOPExperimentalXNW5004 combined with CHOP
Receives: Drug: XNW5004 combined with CHOP (extended)
Phase II, dose expansion stage,CHOEPExperimentalXNW5004 combined with CHOEP
Receives: Drug: XNW5004 combined with CHOEP (extended)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ib/II:Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability].

    Incidence and severity of adverse events that are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

    Measured: through study completion, an average of 1 year

  2. II：Objective response rate (ORR)

    ORR is defined as the proportion of subjects who have a confirmed CR or a PR per lugano2014 assessed by Investigator.

    Measured: 36 months

  3. Ib:Maximum tolerated dose (MTD) and/or the recommended Part 2 dose

    To determine the maximum tolerated dose (MTD) and the recommended Part 2 dose with XNW5004.

    Measured: The first 21-day cycle of therapy

Secondary outcomes (13)

  1. Ib/II:The maximum (peak) blood drug concentration (Cmax) is XNW5004

    Collect blood samples at the specified intervals to determine the Cmax.

    Measured: through study completion, an average of 1 year

  2. Ib/II：XNW5004 Peak Time (Tmax)

    Collect blood samples at the specified intervals to determine the Tmax.

    Measured: through study completion, an average of 1 year

  3. Ib/II：The area under the blood drug concentration-time curve of XNW5004 (AUC)

    Collect blood samples at specified intervals to determine AUC

    Measured: through study completion, an average of 1 year

  4. Ib/II:The maximum (peak) blood drug concentration in the steady state (Css,max)

    Collect blood samples at specified intervals to determine Css,max

    Measured: through study completion, an average of 1 year

  5. Ib/II:XNW5004 Steady-state Baseline Concentration (Css, min)

    Collect blood samples at specified intervals to determine Css, min

    Measured: through study completion, an average of 1 year

  6. Ib/II:The area under the blood drug concentration-time curve (AUCss) under steady-state conditions of XNW5004

    Collect blood samples at specified intervals to determine AUCss

    Measured: through study completion, an average of 1 year

  7. Ib/II:XNW5004 Elimination Half-Life (T1/2)

    Collect blood samples at specified intervals to determine T1/2

    Measured: through study completion, an average of 1 year

  8. Ib/II:Pharmacodynamic indicators, the relative change of H3K27me3 (trimethylation of lysine at position 27 of histone H3) compared to the baseline of histone H3

    Collect blood samples at the specified time to determine the relative changes of H3K27me3 (trimethylation of lysine at position 27 of histone H3) compared to the baseline.

    Measured: through study completion, an average of 1 year

  9. Ib/II:Objective Response Rate (ORR)

    ORR is defined as the Lugano 2014 assessment, representing the proportion of subjects who were diagnosed with CR or PR.

    Measured: 36 months

  10. Ib/II:Disease Control Rate (DCR)

    Rate of complete response [CR], partial response [PR], and stable disease per lugano2014 assessed by Investigator.

    Measured: 36 months

  11. Ib/II:Duration of response (DOR)

    Duration of response (DOR) per lugano2014 assessed by Investigator.

    Measured: 36 months

  12. Ib/II:Progression free survival (PFS)

    Progression free survival (PFS) per lugano2014 assessed by Investigator

    Measured: 36 months

  13. Ib/II：Overall Survival (OS)

    The period from when the patient begins receiving treatment until the patient dies for any reason

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start15 Aug 2025
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07730515
Sponsor's protocol ID
XNW5004-Ib/II-05
Status last verified
Jul 2026
First submitted
8 Jul 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XNW5004 combined with CHOP (incremental), XNW5004 combined with CHOEP (incremental) and XNW5004 combined with CHOP (extended) in people with Non-hodgkin Lymphoma and Peripheral T-cell Lymphoma, run by Evopoint Biosciences Inc. 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 17 inclusion and 35 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 29 Jul 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 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 Linlin.li Li (18678888561, linlin.li@evopointbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ib/II:Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]. (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07730515.

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 29 Jul 2026.

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