再発性または難治性リンパ腫および再発性または難治性節外性ナチュラルキラー/T細胞リンパ腫患者を対象とした静脈内ブリンシドフォビルの第1b/2相試験

基本情報

NCT ID

NCT06761677

ステータス

一時中断

試験のフェーズ

第1/第2相

試験タイプ

介入

目標被験者数

43

治験依頼者名

SymBio Pharmaceuticals

概要

This study is a multi-center, global, open-label, Phase 1b/2 clinical study, and it will be conducted at multiple study sites in several countries, including Japan, Korea, and Singapore, to reveal the safety, tolerability, dose limiting toxicity (DLT), maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), pharmacokinetics (PK), and preliminary efficacy of BCV in patients with relapsed or refractory lymphoma and to assess the efficacy and safety of Brincidofovir (SyB V-1901, BCV) in patients with relapsed or refractory Extranodal Natural Killer/T-cell Lymphoma (ENKL). This study consists of 2 parts and will enroll a total (maximum) of 43 male and female participants who meet the eligibility criteria (Phase 1b part: Up to 18 participants \[3 to 6 participants in each of the 3 cohorts\], Phase 2 part: 25 participants).

対象疾患

介入

依頼者（Sponsor）

実施施設 (6)