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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Junshi Bioscience Co., Ltd.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • JS004 in combination with Toripalimab
  • Bendamustine or gemcitabine

Treatment groups

185 Participants
are divided into 2 treatment groups