study of bgb-a317 in participants with relapsed or refractory mature t- and nk-cell neoplasms

Conditions: 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

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.

Keywords: t/nk-cell nk/t-cell extranodal nasal nk-cell enktl peripheral t-cell anaplastic large cell alcl angioimmunoblastic ptcl-nos relapsed refractory