Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

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).

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

Interventions

DRUG

Tislelizumab

Administered intravenously

Sponsors & Collaborators

• BeiGene

  lead INDUSTRY

Principal Investigators

• Study Director · BeiGene

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-13

Primary Completion

2021-04-21

Completion

2021-04-21

FDA Drug

Yes

Countries

• Canada
• China
• France
• Italy
• Taiwan

Study Locations