Systemic Lupus Erythematosus (SLE)Phase 1/2JY231NCT06675422
JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE)
A Phase 1/2 study testing JY231 injection in people with Systemic Lupus Erythematosus (SLE), run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.
Trial summary
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of active systemic lupus erythematosus (SLE) Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- JY231 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2024to 31 Dec 2026
- Phase
- Phase 1/2
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus International Clinical Collaboration (SLICC) criteria.
- Must have been treated with glucocorticoids in combination with immunosuppressants and/or biologics for at least 2 months prior to screening and have been dose stable for >2 weeks, with the disease remaining active (i.e., prior glucocorticoid + immunosuppressant or glucocorticoid + immunosuppressant + biologics, any of the above medications alone do not qualify). Oral corticosteroids must meet the following requirements: 1) Prednisone (or equivalent) ≥ 7.5 mg/day; 2) When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for corticosteroids.
- positive anti-nuclear antibody (ANA), and/or positive anti-ds-DNA antibody, and/or positive anti-Smith antibody at screening.
- Screening Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >6 and 'clinical' SLEDAI-2K score ≥4.
- 1)Note: 'Clinical' SLEDAI-2K is a SLEDAI-2K score that excludes scores attributable to any urine or laboratory findings, including immunological indicators: 2)-Includes scores for the following clinical items: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, or vasculitis; 3)-excludes scores attributable to fever, SLE headache and organic brain syndromes.
- 5.British Isles Lupus Assessment Group 2004 (BILAG2004) score of at least one of the following:
- ≥1 organ system BILAG2004 grade A disease
- ≥2 organ system BILAG2004 Grade B disorders 6.Physician's General Assessment (PGA) score of ≥1.0 (0-3 visual analogue scale VAS) at screening.
Who cannot join
- Combination of other autoimmune diseases requiring systemic therapy.
- SLE patients: the presence of still uncontrolled lupus crisis within 8 weeks prior to screening, including acute progressive lupus nephritis, severe neuropsychiatric lupus, severe haemolytic anaemia, severe immune thrombocytopenia, granulocyte deficiency, severe cardiac damage, severe lupus pneumonitis, severe lupus hepatitis, severe vasculitis, etc., which were assessed as unsuitable for participation in the study by the investigator.
- Pre-screening comorbidity with clinically significant central nervous system disease or pathological changes not due to lupus, including but not limited to: cerebral vascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndromes, or psychosis.
- History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (e.g., kidney, lung, heart, liver) or future plans for such transplantation.
- Presence of clinically significant cardiovascular dysfunction in the 12 months prior to screening, including, but not limited to: class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina pectoris, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia.
- Presence of significant pulmonary or cardiac manifestations such as pericarditis, pleural effusion at the time of screening, assessed by the investigator to be unsuitable for participation in this study.
Show all 21Show fewer
- Patients with severe asthma or chronic obstructive pulmonary disease (COPD), mild or moderate asthma or COPD on stable therapy may be enrolled.
- History of malignancy within 5 years prior to signing the Informed Consent Form (ICF), except adequately treated or surgically resected, non-melanoma skin cancers or carcinoma in situ (e.g., cervical cancer, bladder cancer, breast cancer) without residual disease.
- Women who are pregnant or breastfeeding.
- History of recurrent infections requiring hospitalisation and intravenous antibiotics (e.g. 3 or more episodes of the same type of infection in the past 1 year).
- Active infection requiring systemic treatment, such as infectious pneumonia, tuberculosis, etc., within 2 weeks prior to clearance.
- Hepatitis B surface antigen (HBsAg) positive, or Hepatitis B core antibody (HBcAb) positive and peripheral blood Hepatitis B Virus (HBV) DNA test positive; Hepatitis C Virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive.
- Have received a live attenuated vaccine within 4 weeks prior to clearance or plan to receive a live attenuated vaccine during the course of the study.
- Have received high-dose corticosteroids (prednisone ≥ 60 mg/day or equivalent) within 4 weeks prior to clearance, or are unable to taper prednisone to ≤ 10 mg/day 5 days prior to clearance.
- Inability to taper or elute background therapy prior to clearing chemotherapy as described in Table 3.
- Receiving renal replacement therapy within 3 months prior to screening or anticipating the need for renal replacement therapy during the study.
- History of drug or alcohol abuse within 1 year prior to screening.
- History or evidence of suicidal thoughts within 6 months prior to screening or any suicidal behaviour within the previous 12 months that the investigator considers to be a significant risk of suicide.
- Use of another study drug within 4 weeks or 5 half-lives (whichever is longer) prior to screening.
- History of hypersensitivity or life-threatening reaction to the study drug or any component or preparation of the study treatment (including clear chemotherapy). See the Investigator's Brochure (IB) for more information about the components of the study drug.
- Any condition that, in the opinion of the investigator, may affect participation in the study, pose a safety risk to patients, or may confound the interpretation of study results.
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
920th HJointLogistics
Kunming, Yunnan
Sanbin Wang, +8613187424131, sanbin1011@163.com
Sanbin Wang, doctor
About this study
Official title: JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE) - A Safety, Tolerability, and Efficacy Study
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of active systemic lupus erythematosus (SLE)
Read the detailed description
This is a single-center, single-arm. open-label clinical study, in this study. approximately 10-20 patients with active systemic lupus erythematosus (SLE) will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after therapy. Evaluate the effectiveness of JY231 treatment.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- JY231 injection
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JY231 injectionDrug
Dose escalation was carried out using the 3+3 principle and the mode of administration was intravenous.
| Study group | Role | What they receive |
|---|---|---|
| JY231 injection for the treatment of active systemic lupus erythematosus | Experimental | Not described Receives: Drug: JY231 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (1)
Incidence of Treatment Related adverse events (AEs)
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Measured: Up to 12 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start9 Oct 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanbin Wang, Doctor, Principal investigator, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675422
- Sponsor's protocol ID
- JY-CT-24-005
- Acronym
- JY231
- Status last verified
- Sep 2024
- First submitted
- 4 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE) - A Safety, Tolerability, and Efficacy Study
- ClinicalTrials.gov ID
- NCT06675422
- Acronym / sponsor ID
- JY231 / JY-CT-24-005
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Nov 2024 (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.
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of active systemic lupus erythematosus (SLE)
Detailed description
This is a single-center, single-arm. open-label clinical study, in this study. approximately 10-20 patients with active systemic lupus erythematosus (SLE) will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after therapy. Evaluate the effectiveness of JY231 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JY231 injection for the treatment of active systemic lupus erythematosus | Experimental | Drug: JY231 injection |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus International Clinical Collaboration (SLICC) criteria.
- Must have been treated with glucocorticoids in combination with immunosuppressants and/or biologics for at least 2 months prior to screening and have been dose stable for >2 weeks, with the disease remaining active (i.e., prior glucocorticoid + immunosuppressant or glucocorticoid + immunosuppressant + biologics, any of the above medications alone do not qualify). Oral corticosteroids must meet the following requirements: 1) Prednisone (or equivalent) ≥ 7.5 mg/day; 2) When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for corticosteroids.
- positive anti-nuclear antibody (ANA), and/or positive anti-ds-DNA antibody, and/or positive anti-Smith antibody at screening.
- Screening Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >6 and 'clinical' SLEDAI-2K score ≥4.
- 1)Note: 'Clinical' SLEDAI-2K is a SLEDAI-2K score that excludes scores attributable to any urine or laboratory findings, including immunological indicators: 2)-Includes scores for the following clinical items: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, or vasculitis; 3)-excludes scores attributable to fever, SLE headache and organic brain syndromes.
Key exclusion criteria (21 listed)
- Combination of other autoimmune diseases requiring systemic therapy.
- SLE patients: the presence of still uncontrolled lupus crisis within 8 weeks prior to screening, including acute progressive lupus nephritis, severe neuropsychiatric lupus, severe haemolytic anaemia, severe immune thrombocytopenia, granulocyte deficiency, severe cardiac damage, severe lupus pneumonitis, severe lupus hepatitis, severe vasculitis, etc., which were assessed as unsuitable for participation in the study by the investigator.
- Pre-screening comorbidity with clinically significant central nervous system disease or pathological changes not due to lupus, including but not limited to: cerebral vascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndromes, or psychosis.
- History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (e.g., kidney, lung, heart, liver) or future plans for such transplantation.
- Presence of clinically significant cardiovascular dysfunction in the 12 months prior to screening, including, but not limited to: class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina pectoris, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia.
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 |
|---|---|---|
| JY231 injectionDose escalation was carried out using the 3+3 principle and the mode of administration was intravenous. | Drug | JY231 injection for the treatment of active systemic lupus erythematosus |
Primary outcome
Objective Response Rate
Time frame: From enrollment to the end of treatment at 6 months
1 secondary outcome
Incidence of Treatment Related adverse events (AEs)
Time frame: Up to 12 months after infusion
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 5 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus (SLE)
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
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.
Sanbin Wang, Doctor principal investigator
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JY231 injection in people with Systemic Lupus Erythematosus (SLE), run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China 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 8 inclusion and 21 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 5 Nov 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sanbin Wang, Doctor (+8613187424131, sanbin1011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From enrollment to the end of treatment at 6 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 5 Nov 2024.