The study is being conducted to compare JS004 plus Toripalimab with Investigator-Selected Chemotherapy in Patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL)
Age at least 18 years old, both males and females are eligible
Pathologically confirmed classical Hodgkin Lymphoma (cHL) with either relapsed (disease progression after achieving CR/PR in recent treatment) or refractory (failure to achieve CR/PR in recent treatment) status.
Has exhausted all standard treatment and refractory to PD-(L)1 monoclonal antibody (mAb)
ECOG: 0-2
Known allergy or contraindication to the investigational drug or its components
Permanent discontinuation of anti-PD-(L)1 antibody due to immune-related adverse reactions.
Presence of central nervous system (CNS) metastasis.
Presence of pleural effusion, ascites, or pericardial effusion requiring intervention (e.g., aspiration, drainage)
Parallel
JS004 in combination with Toripalimab
Biological/VaccineParticipants 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.
Bendamustine or gemcitabine
DrugParticipants 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.
Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC)
PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by IRC or death due to any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 assessed by Investigator or death due to any cause, whichever occurs first.
Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria 2014 assessed by Investigator
Complete response rate (CRR) per Lugano criteria 2014 Assessed by Investigator
Complete response rate (CRR) is defined as the proportion of subjects in which BoR is CR, best overall response (BoR) refers to the best response as determined by the investigator.
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