XNW5004 Phase 2 Study, 65 Subjects, Follicular Lymphoma
Summary
A new Phase 2 clinical trial (NCT07545603) evaluating XNW5004 tablets for relapsed or refractory follicular lymphoma has been registered on ClinicalTrials.gov. The single-arm, open-label, multicenter study plans to enroll 65 subjects with EZH2 wild-type disease, who will receive 1200 mg of study drug twice daily in 28-day cycles for up to 48 weeks of initial treatment, with tumor assessments every 8 weeks. This registry entry provides investigators, patients, and sponsors with a formal record of study design, eligibility criteria, and procedural schedule.
“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).”
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What changed
ClinicalTrials.gov has published a new registry entry for a Phase 2 study (NCT07545603) of XNW5004 tablets as monotherapy for relapsed or refractory follicular lymphoma (EZH2 wild-type). The single-arm, open-label, multicenter trial will enroll 65 subjects who will receive 1200 mg of study drug twice daily in 28-day cycles, with tumor assessments every 8 weeks for the first 48 weeks and every 12 weeks thereafter. The study includes pre-screening, screening, treatment, and long-term follow-up phases with safety and quality-of-life assessments per protocol schedule.
For pharmaceutical sponsors, contract research organizations, and clinical investigators, this registry entry serves as a public reference for trial design and enrollment parameters. Patients and treating physicians may use this record to identify active clinical trial options. The NCT identifier enables cross-referencing with related regulatory submissions, including any future IND filings or agency communications related to this study program.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma
Phase 2 NCT07545603 Kind: PHASE2 Apr 22, 2026
Abstract
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 (±...
Conditions: Follicular Lymphoma, Grade 1, Follicular Lymphoma, Grade 2, Follicular Lymphoma, Grade 3, Follicular Lymphoma Grade 3A
Interventions: XNW5004 tablets
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