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.
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.
Prior radiotherapy is permitted; radiotherapy alone is not considered a systemic therapy.
Availability of sufficient biological samples for EZH2 mutation testing.
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.
Single group
XNW5004 tablets
DrugOral 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).
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.
DCR
Other efficacy endpoints as assessed by IRC, including disease control rate (DCR)
TTR
Other efficacy endpoints as assessed by IRC, including disease control rate (TTR)
DOR
Other efficacy endpoints as assessed by IRC, including duration of response (DOR)
PFS
Other efficacy endpoints as assessed by IRC, including disease control rate (PFS)
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