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Relapsed/Refractory Peripheral T Cell LymphomaPhase 2NCT06702605

To Evaluate XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma

A Phase 2 study testing XNW5004 tablets in people with Relapsed/Refractory Peripheral T Cell Lymphoma, run by Evopoint Biosciences Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open-label, multi-center clinical study to evaluate the efficacy and safety of XNW5004 tablets in subjects with R/R PTCL. The study plans to enroll approximately 50 subjects. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
XNW5004 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Nov 2024to Jan 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

  • 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 >=2 prior systemic treatment lines, including at least one new drug; subjects with CD30 positive ALCL requires 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.
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  • 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 as defined in the following requirements.
  • 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.

Who cannot join

  • Prior exposure to EZH2 inhibitor(s) or EZH1/2 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.
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  • 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 are HBsAg positive and have HBV-DNA copy numbers higher than the lower normal limit of the detection value, or subjects who are anti HBc positive and have HBV-DNA copy numbers higher than the lower normal limit of the detection value. Subjects with HCV antibody positive and HCV-RNA copy number higher than the lower normal limit of the detection value.
  • Subjects with difficulties to swallow the study drug or conditions that significantly affect gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, clinically symptomatic inflammatory bowel disease, or incomplete/complete intestinal obstruction.
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zhiming Li M.D. contact

13719189172

lizhm@sysucc.org.cn

Hui Zhou M.D. contact

13975879796

zhouhui@hnca.org.cn

About this study

Official title: A Phase II Clinical Study of XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma

This is an open-label, multi-center clinical study to evaluate the efficacy and safety of XNW5004 tablets in subjects with R/R PTCL. The study plans to enroll approximately 50 subjects.

Being tested
XNW5004 tablets
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.

  • XNW5004 tabletsDrug

    XNW5004 will be administered orally as tablets.

Study groups in NCT06702605
Study groupRoleWhat they receive
XNW5004ExperimentalXNW5004 tablets Oral administration, twice daily, with a 28-day continuous dosing as one cycle.
Receives: Drug: XNW5004 tablets

What is being measured

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

  1. Objective response rate (ORR) assessed by independent review committee (IRC)

    Percentage of participants achieving complete response (CR) and partial response (PR) in the study.

    Measured: 24 mounths

Secondary outcomes (5)

  1. ORR assessed by investigator

    Percentage of participants achieving complete response (CR) and partial response (PR).

    Measured: 24 mounths

  2. Progression free survival

    time from the first dose of to the first disease progression(PD) or death

    Measured: 24 mounths

  3. Time to Response

    time from the first dose of XNW5004 to first CR or PR

    Measured: around 4 months

  4. Duration of response

    time from the first CR or PR to the first PD or death

    Measured: 24 mounths

  5. Overall survival

    time from the fist dose of XNW5004 to death

    Measured: around 5 years

Timeline

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

  1. First posted25 Nov 2024
  2. Study startNov 2024 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06702605
Sponsor's protocol ID
XNW5004-II-02
Status last verified
Nov 2024
First submitted
20 Nov 2024
Last updated
25 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XNW5004 tablets in people with Relapsed/Refractory Peripheral T Cell Lymphoma, run by Evopoint Biosciences Inc..

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 11 inclusion and 34 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: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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 Zhiming Li M.D. (13719189172, lizhm@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) assessed by independent review committee (IRC) (time frame: 24 mounths). 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 NCT06702605.

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 25 Nov 2024.

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