A Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK- Neoplasms

Official Title

A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK- Neoplasms


This is a multi-centre, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in patients with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There will be two cohorts of patients: - Cohort 1: Patients with relapsed or refractory extranodal NK/T cell lymphoma (nasal or non-nasal type) - Cohort 2: other mature T-cell neoplasms (limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, or anaplastic large-cell lymphoma) - Cohort 3: cutaneous T-cell lymphoma (limited to mycosis fungoides and Sèzary syndrome) Up to 70 patients will be enrolled into cohort 1, up to 50 patients into cohort 2, and up to 10 patients into cohort 3 for a total sample size of up to 130 patients. The primary efficacy endpoint is overall response rate (ORR) determined by investigator assessment. Disease response for the primary endpoint for cohorts 1 and 2 will be assessed per the Lugano criteria with LYRIC modification for immunomodulatory therapy Disease response for the primary endpoint for cohort 3 will be assessed per the ISCL/EORTC guidelines for immunomodulatory therapy BGB-A317 will be administered intravenously as a 200 mg infusion every 3 weeks (Each cycle consists of 21 days). Study procedures will occur over a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all AEs and SAEs); Survival follow-up phase (duration varying by patient).

Trial Description

Primary Outcome:

  • Objective response rate (ORR)
Secondary Outcome:
  • Duration of response (DOR)
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Rate of complete response
  • Time to Response (TTR)

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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