BridgeMD
New treatment option for Follicular Lymphoma, Grade 1
Official title Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma
ClinicalTrials.gov ID: NCT07545603
What this study is testing
What is XNW5004 tablets?
XNW5004 tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for follicular lymphoma, grade 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-arm, open-label, multicenter Phase II clinical study designed to enroll 65 subjects with relapsed or refractory follicular lymphoma (EZH2 wild-type). The study procedures include a pre-screening phase, screening phase, treatment phase, and follow-up phase.Eligible subjects will enter the treatment phase and receive 1200 mg of XNW5004 tablets twice daily, with a 10-14-hour interval between doses.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years; no gender restriction.
- Histologically confirmed follicular lymphoma (FL) grade 1-3a (classic FL per WHO 2022 classification) with wild-type EZH2, as assessed at the study...
- Relapsed or refractory disease following at least 3 prior lines of systemic therapy, including at least one line with adequate treatment using a...
- Prior radiotherapy is permitted; radiotherapy alone is not considered a systemic therapy.
- Availability of sufficient biological samples for EZH2 mutation testing.
You likely can't join if
- Follicular lymphoma grade 3b, mixed histology, potential for transformation, or documented histologic transformation.
- Prior treatment with an EZH2 inhibitor or EZH1/2 inhibitor (including but not limited to tazemetostat).
- Known hypersensitivity to the investigational product, its active ingredients, or excipients.
- Received chemotherapy, immunotherapy, radiotherapy, targeted therapy, antitumor traditional Chinese medicine, or other antitumor therapy within 4...
- Received investigational antitemporal agents not approved in China within 28 days prior to initiation of study treatment.
- Underwent major surgery within 4 weeks prior to initiation of study treatment, or planning major surgery during the study period (excluding...
See the full eligibility criteria
Who can join
- Age ≥ 18 years; no gender restriction.
- Histologically confirmed follicular lymphoma (FL) grade 1-3a (classic FL per WHO 2022 classification) with wild-type EZH2, as assessed at the study site.
- Relapsed or refractory disease following at least 3 prior lines of systemic therapy, including at least one line with adequate treatment using a commercially available anti-CD20 monoclonal antibody and at least one line...
- Prior radiotherapy is permitted; radiotherapy alone is not considered a systemic therapy.
- Availability of sufficient biological samples for EZH2 mutation testing.
- At least one measurable lesion: nodal lesion with longest diameter \>1.5 cm; extranodal lesion with longest diameter \>1.0 cm and FDG-PET positive.
- Life expectancy ≥12 weeks.
- ECOG performance status 0 or 1. Adequate organ function: Hematologic function:
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L (≥1.0×10⁹/L if bone marrow involvement); no G-CSF within 1 week or long-acting G-CSF within 2 weeks before screening CBC. Platelets ≥90×10⁹/L (≥75×10⁹/L if bone marrow...
- Women of childbearing potential must have a negative serum pregnancy test at study entry and agree to use highly effective contraception from study start until at least 6 months after last dose of study drug...
- Signed and dated written informed consent prior to any study-specific procedures, and ability to comply with study visits and protocol-required assessments.
What rules you out
- Follicular lymphoma grade 3b, mixed histology, potential for transformation, or documented histologic transformation.
- Prior treatment with an EZH2 inhibitor or EZH1/2 inhibitor (including but not limited to tazemetostat).
- Known hypersensitivity to the investigational product, its active ingredients, or excipients.
- Received chemotherapy, immunotherapy, radiotherapy, targeted therapy, antitumor traditional Chinese medicine, or other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose...
- Received investigational antitemporal agents not approved in China within 28 days prior to initiation of study treatment.
- Underwent major surgery within 4 weeks prior to initiation of study treatment, or planning major surgery during the study period (excluding procedures such as puncture or lymph node biopsy).
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Disease requiring systemic therapy with corticosteroids (\> 10 mg prednisone daily or equivalent) or other immunosuppressive agents within 14 days prior to study drug administration. Inhaled or topical steroids and...
- Received moderate or strong CYP3A4 inhibitors/inducers within 14 days prior to the first dose (see Appendix 4 for details).
- Received live or live-attenuated viral vaccines within 28 days prior to dosing. Inactivated vaccines are permitted.
- History of psychoactive substance abuse or drug addiction (except for insomnia with stable, long-term therapy as assessed by the investigator).
- Toxicities from prior antitumor therapy not recovered to ≤ Grade 1 per NCI-CTCAE version 5.0, except for toxicities deemed by the investigator not to affect patient safety evaluation (e.g., alopecia).
- History of another malignancy within 3 years prior to enrollment that does not meet criteria for clinical cure, except for adequately treated and cured basal cell carcinoma or squamous cell carcinoma of the skin...
- Previous or current central nervous system involvement by lymphoma.
- Previous or current testicular or breast involvement by lymphoma.
- Previous or current hemophagocytic lymphohistiocytosis.
- Previous or current primary or secondary hematologic disorders other than the primary malignant neoplasm that may affect bone marrow function, including immune thrombocytopenia, autoimmune hemolytic anemia, and aplastic...
- Previous or current acute myeloid leukemia (AML).
- Previous or current T-lymphoblastic lymphoma (T-LBL) or T-lymphoblastic leukemia (T-ALL).
- History of any myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal laboratory findings associated with MDS or myeloproliferative neoplasms (MPN).
- Previous or current central nervous system disorders including, but not limited to: epilepsy, paralysis, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis...
- Impaired cardiac function or clinically significant cardiac disease, including any of the following: Acute myocardial infarction within 12 months prior to first dose; Unstable angina; Congestive heart failure (NYHA...
- Tumor invasion of adjacent vital organs, gastrointestinal tract, or blood vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava) with risk of hemorrhage, or risk of esophagotracheal...
- Clinically symptomatic pleural effusion, ascites, or pericardial effusion poorly controlled despite repeated treatment.
- Unexplained fever with body temperature \> 38.0 °C (including tumor fever); body temperature must be within normal range for 2 weeks prior to first dose.
- Systemic active severe infection: at least 2 weeks washout after completion of antifungal therapy (intravenous or oral), at least 1 week washout after completion of other intravenous antimicrobial therapy, and oral...
- History of tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year prior without adequate anti-tuberculosis treatment.
- Positive HIV test or positive syphilis (Anti-TP) test (patients with negative non-treponemal test and syphilis deemed cured by the investigator are not excluded).
- Positive HBsAg with HBV-DNA above the lower limit of detection, or anti-HBc positive with HBV-DNA above the lower limit of detection; positive HCV antibody with HCV-RNA above the lower limit of detection.
- Inability to swallow, or active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or history of gastrectomy, gastric banding, or other conditions affecting drug absorption. Proton pump...
- Known bleeding disorders such as von Willebrand disease or hemophilia.
- Female patients who are pregnant or breastfeeding.
- Patients who may be unable to complete the study for any other reason, or whom the investigator deems ineligible for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.