Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms
Condition: Peripheral T Cell Lymphoma; PTCL; Extranodal NK/T-cell Lymphoma; Extranodal NK/T-cell Lymphoma, Nasal Type; Extranodal NK T Cell Lymphoma; Extranodal NK T Cell Lymphoma, Nasal; Adult Nasal Type Extranodal NK/T-cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Angioimmunoblastic T-Cell Lymphoma Recurrent; Angioimmunoblastic T-Cell Lymphoma Refractory; Peripheral T-cell Lymphoma NOS; Peripheral T-Cell Lymphoma, Not Otherwise Specified; Peripheral T-Cell Lymphoma Refractory; Anaplastic Large Cell Lymphoma; Anaplastic Large Cell Lymphoma, ALK-Positive; Anaplastic Large Cell Lymphoma, ALK-negative; ALK-negative Anaplastic Large Cell Lymphoma; ALK-Positive Anaplastic Large Cell Lymphoma; Cutaneous T-cell Lymphoma
MeSH terms: Lymphoma; Neoplasms; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic; Lymphoma, T-Cell, Cutaneous; Lymphoma, Extranodal NK-T-Cell; Immunoblastic Lymphadenopathy
Intervention: Tislelizumab
Intervention description: Administered intravenously
Intervention MeSH terms: Tislelizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T/NK-cell; NK/T-cell; extranodal; nasal; NK-cell; ENKTL; peripheral T-cell; anaplastic large cell; ALCL; angioimmunoblastic; PTCL-NOS; Relapsed; Refractory

Summary:

      This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to
      evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory
      mature T- and natural killer (NK)-cell neoplasms. There were three cohorts:

        -  Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or
           non-nasal type)

        -  Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies:
           peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell
           lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL)

        -  Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary
           syndrome (SS)

      Study procedures included 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 adverse
      events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration
      varying by participant).
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Confirmed diagnosis of relapsed or refractory extranodal NK/T-cell lymphoma (nasal or
             non-nasal type, peripheral T-cell lymphoma - not otherwise specified,
             angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, mycosis fungoides,
             or Sezary syndrome)

          -  Age 18 years or older

          -  Relapsed or refractory to at least 1 prior systemic therapy

          -  Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) for
             participants in Cohort 1 and 2

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Life expectancy ≥ 6 months

          -  Adequate respiratory function

          -  Adequate bone marrow function

          -  Adequate renal and hepatic function

        Key Exclusion Criteria

          -  Known central nervous system (CNS) involvement by lymphoma

          -  Previously received immune checkpoint therapy

          -  Prior malignancy within the past 3 years, except for curatively treated basal or
             squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix
             or breast, or localized Gleason score 6 or lower prostate cancer

          -  Active autoimmune disease or history of autoimmune diseases that may relapse with some
             exceptions

          -  Severe or debilitating pulmonary disease

          -  Clinically significant cardiovascular disease

          -  Active fungal, bacterial, and/or viral infection requiring systemic therapy

          -  Known infection with HIV or active viral hepatitis B or C infection

          -  Major surgery within 4 weeks of the first dose of study drug

          -  Pregnant or lactating women

          -  Vaccination with a live vaccine within 35 days prior to the first dose of study drug

          -  Hypersensitivity to tislelizumab

          -  Concurrent participation in another therapeutic clinical trial

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.