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

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-o

Trial Details

NCT ID
NCT07545603
Phase
PHASE2
Sponsor
Evopoint Biosciences Inc.
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • XNW5004 tablets
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • 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 co…
  • Adequate anti-CD20 mAb treatment: at least 4 cycles of continuous therapy or disease progression during treatment; subjects not meeting this criter…

For full eligibility, visit ClinicalTrials.gov.

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