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)

Shanghai Junshi Biosciences

Status and phase: Enrolling; Phase 3

Conditions: Hodgkin Lymphoma

Treatments: Biological: JS004 in combination with Toripalimab; Drug: Bendamustine or gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT06170489

JS004-009-III-cHL

Details and patient eligibility

About

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)

Full description

The study is a randomized, open-label, phase III clinical trial. The main objective is to compare the efficacy of JS004 plus Toripalimab with Investigator-Selected Chemotherapy in treating patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL). The study will assess the safety and tolerability of JS004 combined with Toripalimab.

Enrollment: 185 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

185 participants in 2 patient groups

JS004 plus Toripalimab

Experimental group

Description:

JS004 200mg plus Toripalimab 240mg IV on day 1 of each cycle, every 3 weeks for up to 2 years

Treatment:

Biological: JS004 in combination with Toripalimab

Investigator-Selected Chemotherapy

Active Comparator group

Description:

Bendamustine or gemcitabine

Treatment:

Drug: Bendamustine or gemcitabine