Comparing JS004 and Toripalimab to Chemotherapy for Hodgkin Lymphoma
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)
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 |
| Enrollment | 185 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. Academic / other |
| Drugs / interventions | Toripalimab, Chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06170489 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with known allergies to the investigational drugs, CNS metastasis, or active autoimmune diseases may not benefit from this study.
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 performed: Other studies have shown promise in using combination therapies for Hodgkin lymphoma, but this specific combination is being evaluated for the first time.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yuqin Song, Ph.D
- Email: SongYQ_VIP@163.com
- Phone: 010-88196118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.