Clinical trial · Interventional
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)
A Phase III, Randomised, Open-label,, Multi-Center Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1 Monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)
NCT06170489CI-TRIAL-00086611recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine or gemcitabine | Drug | — | UNRESOLVED |
| JS004 in combination with Toripalimab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- JS004 plus Toripalimab
- description
- JS004 200mg plus Toripalimab 240mg IV on day 1 of each cycle, every 3 weeks for up to 2 years
- interventionNames
- Biological: JS004 in combination with Toripalimab
- type
- ACTIVE_COMPARATOR
- label
- Investigator-Selected Chemotherapy
- description
- Bendamustine or gemcitabine
- interventionNames
- Drug: Bendamustine or gemcitabine
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.