JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE)

NCT06675422 | Recruiting Phase 1

• 1 other identifier: JY-CT-24-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of active systemic lupus erythematosus (SLE)

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (1)

• Incidence of Treatment Related adverse events (AEs)

  Up to 12 months after infusion

Study Arms (1)

JY231 injection for the treatment of active systemic lupus erythematosus

EXPERIMENTAL

Drug: JY231 injection

Interventions

JY231 injection DRUG

Dose escalation was carried out using the 3+3 principle and the mode of administration was intravenous.

JY231 injection for the treatment of active systemic lupus erythematosus

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• )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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China: lead

Study Sites (1)

920th HJointLogistics

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sanbin Wang, Doctor

  920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanbin Wang, Doctor

CONTACT

+8613187424131; sanbin1011@163.com

Lin Liu, doctor

CONTACT

+8615559712042; Lystch@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)