NCT06170489

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P25-P50 for phase_3

Timeline
17mo left

Started Dec 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Dec 2023Sep 2027

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

December 28, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Expected
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

December 6, 2023

Last Update Submit

February 26, 2025

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to approximately 36 months

Secondary Outcomes (8)

  • Overall Survival (OS)

    Up to approximately 45 months

  • Progression Free Survival (PFS) per Lugano criteria 2014 Assessed by Investigator

    Up to approximately 36 months

  • Objective Response Rate (ORR) per Lugano criteria 2014 Assessed by Investigator

    Up to approximately 36 months

  • Complete response rate (CRR) per Lugano criteria 2014 Assessed by Investigator

    Up to approximately 36 months

  • Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator

    Up to approximately 36 months

  • +3 more secondary outcomes

Study Arms (2)

JS004 plus Toripalimab

EXPERIMENTAL

JS004 200mg plus Toripalimab 240mg IV on day 1 of each cycle, every 3 weeks for up to 2 years

Biological: JS004 in combination with Toripalimab

Investigator-Selected Chemotherapy

ACTIVE COMPARATOR

Bendamustine or gemcitabine

Drug: Bendamustine or gemcitabine

Interventions

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.

JS004 plus Toripalimab
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.

Investigator-Selected Chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

toripalimabBendamustine HydrochlorideGemcitabine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Yuqin Song, Ph.D

CONTACT

010-88196118SongYQ_VIP@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

December 28, 2023

Primary Completion

May 31, 2025

Study Completion (Estimated)

September 30, 2027

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)