Hodgkin LymphomaPhase 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 3 study testing JS004 in combination with Toripalimab and Bendamustine or gemcitabine in people with Hodgkin Lymphoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- JS004 in combination with Toripalimab and Bendamustine or gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2023to 30 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Huang, 010-88196023, gcp_xy01@bjcancer.org
About this study
Official title: 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)
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)
Read the detailed description
The study is a randomized, open-label, phase III clinical trial. The main objective is to compare the efficacy of JS004 plus Toripalimab with Investigator-Selected Chemotherapy in treating patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL). The study will assess the safety and tolerability of JS004 combined with Toripalimab.
- Conditions
- Hodgkin Lymphoma
- Being tested
- JS004 in combination with Toripalimab, Bendamustine or gemcitabine
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS004 in combination with ToripalimabBiological
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 gemcitabineDrug
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 group | Role | What they receive |
|---|---|---|
| JS004 plus Toripalimab | Experimental | JS004 200mg plus Toripalimab 240mg IV on day 1 of each cycle, every 3 weeks for up to 2 years Receives: Biological: JS004 in combination with Toripalimab |
| Investigator-Selected Chemotherapy | Active comparator | Bendamustine or gemcitabine Receives: Drug: Bendamustine or gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC)
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.
Measured: Up to approximately 36 months
Secondary outcomes (8)
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 45 months
Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 assessed by Investigator or death due to any cause, whichever occurs first.
Measured: Up to approximately 36 months
Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria 2014 assessed by Investigator
Measured: Up to approximately 36 months
Complete response rate (CRR) per Lugano criteria 2014 Assessed by Investigator
Complete response rate (CRR) is defined as the proportion of subjects in which BoR is CR, best overall response (BoR) refers to the best response as determined by the investigator.
Measured: Up to approximately 36 months
Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator
For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by Investigator, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 36 months
Incidence and severity of all adverse events (AE) that occurred during the clinical trial
An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number and sverity of participants who experience an AE will be presented.
Measured: Up to approximately 36 months
PK
To characterize the trough concentrations of JS004 and toripalimab;
Measured: Up to approximately 36 months
Immunogenicity profiles
To characterize incidence and titer of antidrug antibodies (ADA) and/or neutralizing antibodies (Nab);
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start28 Dec 2023
- Primary completion31 May 2025 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170489
- Sponsor's protocol ID
- JS004-009-III-cHL
- Status last verified
- Feb 2025
- First submitted
- 6 Dec 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06170489
- Acronym / sponsor ID
- JS004-009-III-cHL
- Conditions
- Hodgkin Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
The study is a randomized, open-label, phase III clinical trial. The main objective is to compare the efficacy of JS004 plus Toripalimab with Investigator-Selected Chemotherapy in treating patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL). The study will assess the safety and tolerability of JS004 combined with Toripalimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS004 plus Toripalimab | Experimental | Biological: JS004 in combination with ToripalimabJS004 200mg plus Toripalimab 240mg IV on day 1 of each cycle, every 3 weeks for up to 2 years |
| Investigator-Selected Chemotherapy | Active comparator | Drug: Bendamustine or gemcitabineBendamustine or gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS004 in combination with ToripalimabParticipants 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. | Biological | JS004 plus Toripalimab |
| Bendamustine or gemcitabineParticipants 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. | Drug | Investigator-Selected Chemotherapy |
Primary outcome
Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC)
Time frame: 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.
8 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 45 months
Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator
Time frame: Up to approximately 36 months
Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator
Time frame: Up to approximately 36 months
Complete response rate (CRR) per Lugano criteria 2014 Assessed by Investigator
Time frame: Up to approximately 36 months
Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator
Time frame: Up to approximately 36 months
Incidence and severity of all adverse events (AE) that occurred during the clinical trial
Time frame: Up to approximately 36 months
PK
Time frame: Up to approximately 36 months
Immunogenicity profiles
Time frame: Up to approximately 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JS004 in combination with Toripalimab and Bendamustine or gemcitabine in people with Hodgkin Lymphoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqin Song, Ph.D (010-88196118, SongYQ_VIP@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) per Lugano criteria 2014 as Assessed by Independent review committee (IRC) (time frame: Up to approximately 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.