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)
Recruiting now · Phase 3
Conditions studied: Hodgkin Lymphoma
In brief
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)
Key facts
- Study ID
- NCT06170489
- Run by
- Shanghai Junshi Bioscience Co., Ltd.
- People needed
- 185
- Starts
- 2023-12-28
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2025-02-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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