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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)

RECRUITINGPhase 3Sponsored by Shanghai Junshi Bioscience Co., Ltd.
Actively Recruiting
PhasePhase 3
SponsorShanghai Junshi Bioscience Co., Ltd.
Started2023-12-28
Est. completion2025-05-31
Eligibility
Age18 Years+
Healthy vol.Accepted

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)

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerHodgkin Lymphoma

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