Phase III Study Comparing JS004 Plus Toripalimab to Chemotherapy for Patients with PD-L1 Antibody Resistant Classic Hodgkin Lymphoma

What this Trial Is About

Researchers are conducting a phase III clinical trial to compare the combination of JS004 and Toripalimab with Investigator-Selected Chemotherapy in patients who have classic Hodgkin Lymphoma cHL that is resistant to PD-L1 monoclonal antibody treatment. The study aims to evaluate the effectiveness and safety of these treatments in this particular patient group, focusing on those whose disease has relapsed or not responded to prior therapies. Participants will be randomly assigned to one of two treatment groups. One group will receive JS004 200 mg plus Toripalimab 240 mg through intravenous infusion on the first day of each 3-week cycle, continuing for up to 2 years or 35 infusions. The other group will receive Investigator-Selected Chemotherapy, which may include bendamustine or gemcitabine given intravenously according to specified dosing schedules over up to 6 cycles. During the study, participants will be monitored regularly for disease progression using the Lugano criteria, safety and adverse events, and overall survival for up to approximately 36 to 45 months. Assessments will include imaging to measure tumor response, laboratory tests, and evaluations of drug levels and immune responses. This comprehensive monitoring will help researchers understand how well the treatments work and their tolerability over time.

A Phase III Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)