RecruitingPhase 3NCT06170489

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)


Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Enrollment

185 participants

Start Date

Dec 28, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This phase III study is comparing a new drug combination — JS004 (an anti-CD112R antibody) plus toripalimab (an immunotherapy) — against the doctor's choice of chemotherapy in patients with classical Hodgkin lymphoma (a blood cancer) that has relapsed or stopped responding to prior immunotherapy (PD-1 or PD-L1 drugs). **You may be eligible if...** - You are 18 or older - You have been diagnosed with classical Hodgkin lymphoma that has relapsed (came back) or is refractory (did not respond) to previous treatment - You have already tried all standard treatments and your disease no longer responds to PD-1 or PD-L1 immunotherapy - You have at least one measurable tumor on imaging - You are in generally good health (ECOG 0-2) **You may NOT be eligible if...** - You permanently stopped an anti-PD-(L)1 drug due to a serious immune-related side effect - Your cancer has spread to the brain - You have fluid buildup around the lungs, heart, or abdomen requiring drainage - You have active autoimmune diseases requiring ongoing treatment with steroids or immunosuppressants Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALJS004 in combination with Toripalimab

Participants will receive JS004 in combination with Toripalimab (200 mg/240 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions.

DRUGBendamustine or gemcitabine

Participants will receive Investigator-Selected chemotherapy of EITHER bendamustine by IV infusion at a dose of 90 or 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose of 1000 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06170489


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