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Recurrent/Refractory Malignant LymphomaPhase 1NCT04477772

A Phase I Clinical Study of JS004 in Subjects With Recurrent/Refractory Malignant Lymphoma of China

A Phase 1 study testing JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion and Drug：JS001, Intravenous infusion in people with Recurrent/Refractory Malignant Lymphoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A First-in-human, dose-escalation, dose-expansion phase I clinical study of JS004 in subjects with recurrent/refractory malignant lymphoma in China, to evaluate the safety, tolerbility, PK, immunogenicity,antitumor activity and biomarkers of JS004, to define MTD and RP2D of JS004. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Recurrent/Refractory Malignant Lymphoma
What is being tested?
JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion and Drug：JS001, Intravenous infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteChina
Study dates
17 Jul 2020to 14 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Able to understand and sign informed consent voluntarily
  • 2.18-70 years old
  • 3.Pathologically confirmed malignant lymphoma
  • 4.ECOG PS: 0-1
  • 5.Expected survival ≥12 weeks
  • 6.At least one measurable lesion per Lugano response critieria 2014 for Lymphoma
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  • 7.Adequate organ and marrow function, as defined below:
  • ANC≥1.5×109/L;
  • PLT≥100×109/L and ≥75×109/L for subjects with bone marrow involvement;
  • Hb≥90 g/L;
  • TBIL≤1.5 ULN, ≤2 ULN in those with hep109atic metastasis, except subjects with documented Gilbert's syndrome who must have a baseline conjugated bilirubin ≤3.0 mg/dL;
  • AST and ALT≤2.5 ULN, ≤5 ULN in those with hepatic metastasis;
  • Cr≤1.5 UL, or creatinine clearance≥50mL/min for subject;
  • INR ≤2 ULN and aPTT≤1.5×ULN for those with no prior anticoagulant therapy.
  • 8.According to Fridericia's principle, QTC results need to match : Male≤450 ms，Female≤470 ms
  • 9.Females of childbearing potential need to use effective contraception

Who cannot join

  • Patients with known allergy to macromolecular protein preparations or JS004 components
  • Prior exposure to anti-BTLA or anti-HVEM antibodies
  • Enrolled in other clinical studies within 4 weeks prior to the first dose of study treatment
  • Major surgery within 4 weeks prior to the first dose of study treatmentor still recovering from prior surgery
  • Patients who discontinued previous immunotherapy due to immune-related adverse reactions
  • Immunosuppressive agents have been used within 4 weeks prior to the first dose of study treatment
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  • Prior allogeneic bone marrow transplantation or solid organ transplantation
  • Live attenuated vaccine be administered 30 days before the first dose of study treatment
  • Two or more malignancies developed within 5 years prior to first dose of study treatment
  • The patients have symptomatic, untreated, or requiring ongoing treatment central nervous system (CNS) metastases
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to baseline or to NCI-CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia.Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by TAB004 may be included (e.g., hearing loss) after consultation with the medical monitor.
  • Autoimmune disease within the previous 2 years
  • A history of rapid allergic reaction, eczema, or asthma beyond the control of topical corticosteroids
  • A history of primary immunodeficiency
  • Concomitant disease that is not under control, including but not limited to: persistent or active infection, unexplained fever > 38.5°C, or heart disease, active peptic ulcer disease or gastritis
  • A history of active inflammatory bowel disease
  • HIV(+)
  • Patients with evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Pregnant or lactating woman
  • Patients with vitiligo, alopecia, and hormonal replacement therapy have controlled endocrine defects
  • Any other medical factors that may affect subjects' rights, safety, compliance, ability to sign informed consent, and interpretation of study results.
  • Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) in Patients With Recurrent/Refractory Malignant Lymphoma

A First-in-human, dose-escalation, dose-expansion phase I clinical study of JS004 in subjects with recurrent/refractory malignant lymphoma in China, to evaluate the safety, tolerbility, PK, immunogenicity,antitumor activity and biomarkers of JS004, to define MTD and RP2D of JS004. A cycle is 21 days(3 weeks) which includes JS004 being administered IV Q3W and JS004 combine with JS001 being administered IV Q3W. All patients will be treated until disease progression per Lugano response critieria 2014 for Lymphoma or intolerable toxicity per CTCAE 5.0, withdrawal of consent, or end of the study, whichever occurs first. Disease progression must be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of progression.

Being tested
JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion, Drug：JS001, Intravenous infusion
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusionBiological

    Also called TAB004

    Part A: including dose escalation (1mg/kg JS004; 3mg/lg JS004; 10mg/kg JS004), dose expansion (3mg/kg JS004 and 200mg JS004) and indication expansion. Part B: including dose escalation (240mg JS004+100mg JS001; 240mg JS004+ 200mg JS001), dose expansion (240mg JS004+100mg JS001; 240mg JS004+ 200mg JS001) and indication expansion.

  • Drug：JS001, Intravenous infusionBiological

    Part B: including dose escalation (240mg JS004+100mg JS001; 240mg JS004+ 200mg JS001), dose expansion (240mg JS004+100mg JS001; 240mg JS004+ 200mg JS001) and indication expansion.

Study groups in NCT04477772
Study groupRoleWhat they receive
1mg/kg JS004, Q3W until to 2 yearsExperimentalDose escalation, enrolled 3-6 subjects
Receives: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
3mg/kg JS004, Q3W until to 2 yearsExperimentalDose escalation, enrolled 3-6 subjects; Dose expansion, enrolled 9 subjects
Receives: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
10mg/kg JS004, Q3W until to 2 yearsExperimentalDose escalation, enrolled 3-6 subjects
Receives: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
200mg, Q3W until to 2 yearsExperimentalDose expansion, enrolled 9 subjects and indication expansion if RP2D is 200mg
Receives: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
240mg JS004+100mg JS001, Q3W until to 2 yearsExperimentalDose escalation, enrolled 3-6 subjects; Dose expansion, enrolled 6-9 subjects and indication expansion if RP2D is confirmed this arm
Receives: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion; Biological: Drug：JS001, Intravenous infusion
240mg JS004+200mg JS001, Q3W until to 2 yearsExperimentalDose escalation, enrolled 3-6 subjects; Dose expansion, enrolled 6-9 subjects and indication expansion if RP2D is confirmed this arm
Receives: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion; Biological: Drug：JS001, Intravenous infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants and severiaty with treatment-related Adverse events as assessed by CTCAE V5.0

    Safety and Tolerability

    Measured: 2 Years

Secondary outcomes (4)

  1. Objective Response Rate (ORR) per Lugano response critieria 2014 for Lymphoma

    Measured: 2 Years

  2. Duration of Response (DOR) per Lugano response critieria 2014 for Lymphoma

    Measured: 2 Years

  3. Disease Control Rate (DCR) per Lugano response critieria 2014 for Lymphoma

    Measured: 2 Years

  4. Progrssion-free survival (PFS) per Lugano response critieria 2014 for Lymphoma

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start17 Jul 2020
  3. Primary completion14 Mar 2024
  4. Study completion14 Mar 2024

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04477772
Sponsor's protocol ID
JS004-002-I
Status last verified
May 2024
First submitted
16 Jul 2020
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion and Drug：JS001, Intravenous infusion in people with Recurrent/Refractory Malignant 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 16 inclusion and 22 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: finished, as of the sponsor's last update on 16 May 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants and severiaty with treatment-related Adverse events as assessed by CTCAE V5.0 (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04477772.

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 16 May 2024.

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