Tifcemalimab as monotherapy or in combination with toripalimab in patients with relapsed/refractory lymphoma: a Phase I trial.

ABSTRACT: Preclinical studies of tifcemalimab (anti-BTLA antibody) in combination with toripalimab (anti-PD-1 antibody) demonstrated synergistic anti-tumor effects. We present the outcomes of tifcemalimab with or without toripalimab in lymphoma patients. This is a 2-part, phase I study (NCT04477772). In Part A (dose escalation based on 3 + 3 design), patients with relapsed or refractory lymphoma received tifcemalimab monotherapy 1, 3 or 10 mg/kg for dose escalation and 3 mg/kg or 200 mg for dose expansion. For Part B (indication expansion), only classical Hodgkin's lymphoma (cHL) patients were included to receive tifcemalimab 100 or 200 mg plus toripalimab 240 mg due to poor tumor response in other subtypes. The primary endpoints were safety, maximum tolerated dose (MTD) and recommended phase 2 dose

SUBMITTER: Song Y 

PROVIDER: S-EPMC12084519 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature