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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 3Ages 18 Years - anyAllShanghai Junshi Bioscience Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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)

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • JS004 in combination with Toripalimab
  • Bendamustine or gemcitabine
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Where

1 site
Beijing Cancer Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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