NCT06170489 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)
| NCT ID | NCT06170489 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. |
| Condition | Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 185 participants |
| Start Date | 2023-12-28 |
| Primary Completion | 2025-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 185 participants in total. It began in 2023-12-28 with a primary completion date of 2025-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06170489 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06170489 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 185 participants.
Is NCT06170489 currently recruiting?
Yes, NCT06170489 is actively recruiting participants. Contact the research team at SongYQ_VIP@163.com for enrollment information.
Where is the NCT06170489 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06170489 clinical trial?
NCT06170489 is sponsored by Shanghai Junshi Bioscience Co., Ltd.. The trial plans to enroll 185 participants.