Phase III Study of AK129 Alone or With AK117 to Treat Relapsed or Refractory Classic Hodgkin Lymphoma After PD-1L1 Inhibitor Therapy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of AK129, a bispecific antibody targeting LAG-3 and PD-1, alone or combined with AK117, an anti-CD47 monoclonal antibody, in patients with relapse or refractory classic Hodgkin lymphoma cHL who have not responded to prior PD-1L1 inhibitor therapy. This phase III study focuses on patients whose disease has progressed despite previous treatment with PD-1L1 inhibitors. The trial aims to find suitable doses and assess treatment impact in this specific group. The study includes multiple phases. In Phase Ia, participants receive varying doses of AK129 every two weeks. Phase Ib involves treatment with AK129 at different doses plus AK117 at 30 mgkg every two weeks. Phase II continues with AK129 at the recommended Phase II dose from Phase Ib combined with AK117 at the same dose and schedule. Both drugs are given intravenously, and the dosing intervals are consistent across phases. Participants will be monitored for dose-limiting toxicities during the first 28 days after starting treatment and followed for up to two years to assess adverse events and treatment responses. Researchers will measure outcomes such as objective response rate, disease control rate, time to response, duration of response, progression-free survival, overall survival, and drug concentration levels. Safety evaluations and long-term monitoring will ensure comprehensive assessment of treatment effects over time.

A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma