Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma

NCT07545603 | Recruiting Phase 2 DMC

• 1 other identifier: XNW5004-II-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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. Each treatment cycle consists of 28 consecutive days of dosing, and pharmacokinetic (PK) blood samples will be collected at the designated time points.Safety assessments and quality-of-life (QoL) assessments will be performed in accordance with the study follow-up schedule.Tumor assessments will be conducted every 8 weeks (every 2 cycles) for the first 48 weeks after the first dose (Cycles 1 to 12), and every 12 weeks (every 3 cycles) thereafter (from Cycle 13 onward).Subjects who discontinue treatment must complete an end-of-treatment visit and safety follow-up. For long-term follow-up:Subjects who terminate treatment for reasons other than disease progression and do not initiate new antineoplastic therapy will continue tumor assessments per the original schedule until disease progression, initiation of new antineoplastic therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.For all patients (excluding those who withdraw informed consent, are lost to follow-up, or die), survival follow-up will be performed every 12 weeks (±7 days) starting from the date of the last tumor assessment, until withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.

Conditions

Follicular Lymphoma, Grade 2; Follicular Lymphoma Grade 3A; Follicular Lymphoma, Grade 1; Follicular Lymphoma, Grade 3

Keywords

Follicular Lymphoma; Phrase II

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate (ORR) as assessed by Independent Review Committee (IRC) in patients with relapsed or refractory follicular lymphoma (EZH2 wild-type) treated with XNW5004 Tablets.

  24months

Secondary Outcomes (14)

• DCR

  24 months

• TTR

  24 months

• DOR

  24 months

• PFS

  24 months

• OS

  24 months

Study Arms (1)

XNW5004

EXPERIMENTAL

XNW5004 Tablets 1200 mg, twice daily, at an interval of 10-14 hours, with 28 consecutive days of administration as one treatment cycle.

Drug: XNW5004 tablets

Interventions

XNW5004 tablets DRUG

Oral administration of XNW5004 Tablets 1200 mg twice daily with a 10-14 hour interval for 28 consecutive days as one treatment cycle in patients with relapsed or refractory follicular lymphoma (EZH2 wild-type).

XNW5004

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 with adequate treatment using a novel agent (including but not limited to PI3K inhibitors, CD3×CD20 bispecific antibodies, BTK inhibitors, etc.):
• Adequate anti-CD20 mAb treatment: at least 4 cycles of continuous therapy or disease progression during treatment; subjects not meeting this criterion may be included only with a valid justification (e.g., intolerance).
• Adequate novel agent treatment: failure to achieve response, disease progression during treatment, or treatment discontinuation due to intolerance (intolerance defined as meeting treatment discontinuation criteria per the package insert).
• Relapsed disease: relapse ≥6 months after achieving response to any line of therapy.
• Refractory disease, defined by any of the following:
• Response duration \<6 months and ineligible for or unwilling to undergo autologous hematopoietic stem cell transplantation (auto-HSCT); Failure to achieve response after at least 4 cycles of treatment; Best response or treatment discontinuation due to progressive disease, regardless of number of cycles; Relapse after auto-HSCT.
• 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:

You may not qualify 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 weeks or 5 half-lives (whichever is shorter) prior to the first dose; received CAR-T therapy within 12 weeks prior to the first dose; underwent autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months 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 adrenal replacement therapy with ≤ 10 mg prednisone daily or equivalent are permitted in the absence of active autoimmune disease.
• 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, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
• Previous or current central nervous system involvement by lymphoma.
• Previous or current testicular or breast involvement by lymphoma.

Sponsors & Collaborators

• Evopoint Biosciences Inc.: lead

Study Sites (1)

Beijing Cancer Hospitial

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuqin Song, PhD

  Beijing Cancer Hospitial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqin Song

CONTACT

+86 010-88196118; songyuqin622@163.com

Qiye Wang

CONTACT

+86 18036617186; qiye.wang@evopointbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 22, 2026
• Study Start: February 14, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)