Actively Recruiting
A Phase III Randomized Open-label Multi-Center Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1 Monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2025-02-28
185
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase III clinical trial to compare the combination of JS004 and Toripalimab with Investigator-Selected Chemotherapy in patients who have classic Hodgkin Lymphoma (cHL) that is resistant to PD-(L)1 monoclonal antibody treatment. The study aims to evaluate the effectiveness and safety of these treatments in this particular patient group, focusing on those whose disease has relapsed or not responded to prior therapies. Participants will be randomly assigned to one of two treatment groups. One group will receive JS004 (200 mg) plus Toripalimab (240 mg) through intravenous infusion on the first day of each 3-week cycle, continuing for up to 2 years or 35 infusions. The other group will receive Investigator-Selected Chemotherapy, which may include bendamustine or gemcitabine given intravenously according to specified dosing schedules over up to 6 cycles. During the study, participants will be monitored regularly for disease progression using the Lugano criteria, safety and adverse events, and overall survival for up to approximately 36 to 45 months. Assessments will include imaging to measure tumor response, laboratory tests, and evaluations of drug levels and immune responses. This comprehensive monitoring will help researchers understand how well the treatments work and their tolerability over time.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at least 18 years old, both males and females are eligible
- Pathologically confirmed classical Hodgkin Lymphoma (cHL) with relapsed or refractory status
- Must be refractory to PD-(L)1 monoclonal antibody treatment and have exhausted all standard treatments
- ECOG performance status between 0 and 2
- At least one measurable lesion as per Lugano 2014 response assessment
You will not qualify if you...
- 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
- Active autoimmune diseases requiring systemic treatment within the past 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 years
Participants receive either JS004 plus Toripalimab by intravenous infusion every 3 weeks for up to 2 years, or Investigator-Selected Chemotherapy with bendamustine or gemcitabine according to prescribed cycles.
Infusions every 3 weeks for up to 35 cycles or chemotherapy cycles up to 6 cycles depending on assigned treatment
Duration - Up to approximately 36 months
Participants are monitored for progression-free survival, overall survival, adverse events, and treatment response after completing treatment.
Regular follow-up visits over up to 3 years
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
Y
Yuqin Song, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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