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)

PHASE3RecruitingINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

December 28, 2023

Primary Completion Date

May 31, 2025

Study Completion Date

September 30, 2027

Conditions
Hodgkin Lymphoma
Interventions
BIOLOGICAL

JS004 in combination with Toripalimab

Participants will receive JS004 in combination with Toripalimab (200 mg/240 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions.

DRUG

Bendamustine or gemcitabine

Participants will receive Investigator-Selected chemotherapy of EITHER bendamustine by IV infusion at a dose of 90 or 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose of 1000 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.

Trial Locations (1)

100142

RECRUITING

Beijing Cancer Hospital, Beijing

All Listed Sponsors
lead

Shanghai Junshi Bioscience Co., Ltd.

OTHER