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Autoimmune DiseasesNCT06887985

JY231(JY231) Injection for the Treatment of Refractory Autoimmune Diseases (ADs)

A study testing JY231 Injection in people with Autoimmune Diseases, run by He Huang.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with Refractory Autoimmune Diseases (ADs). It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of Refractory Autoimmune… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Autoimmune Diseases
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
45 participants
Where
No sites listed yet
Study dates
31 Mar 2025to 31 Dec 2027
Phase
Interventional
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18~75 years old, male or female, signed informed consent (ICF);
  • Diagnosis of one of the following diseases:
  • Systemic Lupus Erythematosus (SLE), European League Against Rheumatism/ (EULAR)/American College of Rheumatology(ACR) 2019 criteria), and Antinuclear Antibodies(ANA) > 1:80 or ds-DNA positive;
  • Dry syndrome (SS), 2016 ACR/EULAR criteria and at least Sjögren's Syndrome Antigen A(SSA) positive;
  • Systemic sclerosis (SSc), 2013 ACR/EULAR criteria and ANA > 1:80 or anti-Scleroderma(SCL)-70 positive;
  • Dermatomyositis (DM), 2017 EULAR/ACR classification criteria and positive for any of the myositis-specific antibodies (Jo-1), Zo, Anti-Glycyl-Transfer Ribonucleic Acid(tRNA) Synthetase Antibody(EJ), Anti - Threonyl - tRNA Synthetase Antibody(PL-7), Anti-Aspartyl-tRNA Synthetase Antibody(KS), Anti-isoleucyl-tRNA Synthetase Antibody(OJ), PL-12, Anti-Tyrosyl-tRNA Synthetase Antibody(YRS), Anti-nuclear matrix protein(NXP)-2, Anti - transcription intermediary factor 1 gamma Antibody(Anti-TIF1g), Anti-Mi-2, Anti-small ubiquitin - like modifier - activating enzyme Antibody(Anti-SAE), Anti-MDA-5, Anti-signal recognition particle Antibody(Anti-SRP), Anti-HMGCR);
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  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA-AAV), including granulomatous polyangiitis (GPA), or microscopic vasculitis (MPA), or eosinophilic granulomatous polyangiitis (EGPA),2022 ACR/EULAR criteria, and ANCA antibody-positive, including c-ANCA/p-ANCA/anti Proteinase 3(PR3)/anti-Myeloperoxidase(MPO) positive.
  • Patients who have been treated with ≥2 immunosuppressive agents for 6 months, or who are intolerant to standard therapy, or who have relative contraindications, and whose disease activity meets the following criteria:
  • For SLE patients, SLEDAI≥ 8 points;
  • For SS patients, European League Against Rheumatism Sjögren's Syndrome Disease Activity Index(ESSDAI) ≥ 14 points;
  • For SSc patients with an Modified Rodnan Skin Score(mRSS) score between 10-35 (inclusive of the cutoff), combined with interstitial lung disease (ILD);
  • For DM patients, 1 year after diagnosis, and the following conditions are met:
  • ① Rash VAS score (based on MDAAT) ≥ 3 cm and at least 3 CSM abnormalities;
  • ②Muscle biopsy pathology or muscle nuclear magnetic resonance suggestive of active inflammation;
  • ③ Bilateral Manual Muscle Testing (MMT-8) < 125/150 and at least 2 additional Core set measures (CSM) meeting the criteria specified below: a. Patient scores on a 10 cm Visual Analog Scale (VAS) with a minimum of 2.0 cm; b. Physician scores on a 10 cm VAS with a minimum of 2.0 cm; c. Health Assessment Questionnaire (HAQ) Disability Index with a minimum value of 0.25; d. Elevation of at least one muscle enzyme (including creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), and aspartate aminotransferase (AST)), with a minimum level of 1.3 x the upper limit of normal; and e. Extramuscular Organ Disease Activity Score with a minimum level of 1.3 x the upper limit of normal on a 10 cm VAS scale. minimum of 1.0 cm on a 10 cm VAS scale (This VAS is a physician's comprehensive assessment based on the Myositis Disease Activity Assessment Tool (MDAAT) which evaluates activity scores on the General Condition, Skin, Skeletal, Gastrointestinal, Lung, and Cardiac scales);
  • For ANCA-AAV patients, British Vasculitis Activity Score(BVAS) score ≥15,and ANCA antibody.
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1 point;
  • Critical organ function assessment meets the following conditions:
  • Blood: hemoglobin ≥60g/L, platelet count ≥20×109/L;
  • Cardiac function: left ventricular ejection fraction (LVEF) ≥55%, ECG without obvious abnormalities;
  • Renal function: Estimated Glomerular Filtration Rate(eGFR) ≥30 mL/min/1.73m2;
  • Liver function: AST and ALT ≤ 3.0 upper limit of normal(ULN) and total bilirubin ≤ 2.0 ULN;
  • Have criteria for single or venous blood collection and no other contraindications to cell collection;
  • Subjects of childbearing age with negative urine pregnancy test results and agree to use effective contraception during the study until 1 year post-infusion;
  • The patient or his/her guardian agrees to participate in the study and signs an informed consent form, indicating that he/she understands the purpose and procedures of the study and is willing to participate in the study.

Who cannot join

  • Have received prior CAR-T cell therapy;
  • Suffering from severe cardiac, hepatic, pulmonary, hematologic, or endocrine system disorders that, in the judgment of the investigator, outweigh the risks of participation in the study;
  • Active or uncontrollable infection requiring systemic therapy within 1 week prior to screening;
  • Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) positive and peripheral blood Hepatitis B virus (HBV) DNA titer test is greater than the normal reference range; or Hepatitis C virus (HCV) antibody positive and peripheral blood Hepatitis C virus (HCV) RNA titer test is greater than the normal reference range; or Human Immunodeficiency Virus (HIV) antibody positive; or positive syphilis test; or positive cytomegalovirus (CMV) DNA test;
  • Have received a live vaccine within 4 weeks prior to screening;
  • Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 2 years of their JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years of their JY231 injection infusion;
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  • Patients with malignant diseases such as malignant tumors prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
  • Patients who have participated in another clinical study within 3 months prior to screening;
  • Other conditions that the investigator considers unsuitable for participation in the study.

About this study

Official title: An Early Exploratory Clinical Study of the Safety, Tolerability, and Initial Efficacy of JY231 Injection for the Treatment of Refractory Autoimmune Diseases (ADs)

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with Refractory Autoimmune Diseases (ADs). It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of Refractory Autoimmune Diseases (ADs).

Read the detailed description

This study included the screening period (Day -18 to Day -7), the baseline period (Day -1), the treatment and observation period (Day 0 to 28), and the follow-up period (Month 2[from Day 29] to Year 15). Participants eligible for the screening period will be admitted to the study center for a single JY231 treatment and a follow-up period after the end of the treatment and observation period. After completing the follow-up for the first five years, methods such as telephone or written questionnaires can be used, and relevant samples should be collected as much as possible. The subjects should be followed up at least once a year until the end of the follow-up period. The maximum monitoring time can be extended to 15 years, and all monitoring data during the extension process need to be recorded.

Being tested
JY231 Injection
Medical subject headings
Autoimmune Diseases

What participants receive

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

  • JY231 InjectionDrug

    This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo chimeric antigen receptor T-Cell (CAR-T cell) therapy in patients with relapsed refractory B-cell leukemia.

    Upon enrollment, subjects will receive an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be hospitalized for one month for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 15 years to determine if the disease is under control.

Study groups in NCT06887985
Study groupRoleWhat they receive
A single-center, open, single arm studyExperimentalJY231 injection for the treatment of refractory autoimmune diseases (ADs) subjects who meet the inclusion criteria will receive a single intravenous injection of JY231, followed by regular observation and follow-up of the subject.
Receives: Drug: JY231 Injection

What is being measured

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

  1. Incidence of adverse events(AE) after infusion

    The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

    Measured: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24

  2. Maximal Tolerated Dose(MTD)

    MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.

    Measured: Up to 28 days after infusion

Timeline

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

  1. First posted21 Mar 2025
  2. Study start31 Mar 2025 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06887985
Sponsor's protocol ID
JY-CT-24-007
Status last verified
Mar 2025
First submitted
19 Mar 2025
Last updated
21 Mar 2025
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 study testing JY231 Injection in people with Autoimmune Diseases, run by He Huang.

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 25 inclusion and 9 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: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

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?

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?

Incidence of adverse events(AE) after infusion (time frame: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24). The study lists 2 primary outcomes in all. 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 NCT06887985.

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 21 Mar 2025.

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