Comparing JS004 and Toripalimab to Chemotherapy for Hodgkin Lymphoma
Official title: 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)
Run by Shanghai Junshi Bioscience Co., Ltd. · NCT06170489 · Data updated 2026-11-12
This study is testing if a new combination of JS004 and Toripalimab can work better than regular chemotherapy for people with Hodgkin lymphoma who haven't responded to previous treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 185 (estimated) |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. Academic / other |
| Drugs / interventions | Toripalimab, Chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | December 28, 2023 |
| Main results expected | May 31, 2025 |
| Study ends | September 30, 2027 |
| Registry record updated | February 28, 2025 |
| Trial ID | NCT06170489 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with pathologically confirmed classic Hodgkin lymphoma who have not responded to previous PD-(L)1 monoclonal antibody treatments.
✕Probably not a fit
Patients with known allergies to the investigational drugs, CNS metastasis, or active autoimmune diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III clinical trial aims to evaluate the effectiveness of JS004 combined with Toripalimab against investigator-selected chemotherapy in patients with classic Hodgkin lymphoma who are refractory to PD-(L)1 monoclonal antibodies. The study is randomized and open-label, focusing on patients who have either relapsed or refractory disease after standard treatments. It will assess both the efficacy and safety of the combination therapy compared to traditional chemotherapy options.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with refractory classic Hodgkin lymphoma.
How similar studies have gone: Other studies have shown promise in using combination therapies for Hodgkin lymphoma, but this specific combination is being evaluated for the first time.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Yuqin Song, Ph.D
- Email: SongYQ_VIP@163.com
- Phone: 010-88196118
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.