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)

• Status: Recruiting
• Trial end date: 2027-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.
• Treatments: Bendamustine Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be enrolled:

• 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

• At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment.

Exclusion Criteria:

• 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)

• Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years