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Clinical Trials in China / NCT06170489
Recruiting Phase 3

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)

NCT06170489 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Junshi Bioscience Co., Ltd
Phase
Phase 3
Started
2023-12-28
Last updated
2025-02-28

Condition(s) studied

Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

JS004 in combination with ToripalimabAll Tifcemalimab trials (5) →All Toripalimab trials (200) →Bendamustine or gemcitabineAll Bendamustine trials (53) →All Gemcitabine trials (385) →

JS004 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.

Bendamustine 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC) — Up to approximately 36 months
    PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by IRC or death due to any cause, whichever occurs first.

Trial sites (1)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting

More Shanghai Junshi Bioscience Co., Ltd. trials in China

JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma. Recruiting
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour Recruiting
JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma Recruiting
A Clinical Study to Evaluate the Efficacy and Safety of JS212 Monotherapy or Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC) Recruiting
A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer Recruiting

Other trials for the same condition

Prognostic Model of Elderly Hodgkin Lymphoma in China Active, not recruiting
The Pathogenesis and Prognostic Factors of Lymphoma Recruiting
PD-1 Antibody and JAK1 Inhibitor for Newly Diagnosed Pediatric Hodgikin's Lympoma Starting soon
CCCG-HD-2018 for Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma Active, not recruiting
AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06170489 on ClinicalTrials.gov ↗ ← All trials in China