Autoimmune DiseasesEarly Phase 1JY231、ADsNCT06243159
JY231(Internal Clinical Drug Code) Injection for the Treatment of Refractory Autoimmune Diseases
A Early Phase 1 study testing JY231 in people with Autoimmune Diseases, run by Shanxi Bethune Hospital 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 refractory autoimmune diseases Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- JY231
- 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
- 8 Feb 2024to 31 Dec 2026
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old, regardless of gender, signed with informed consent (ICF).
- Diagnosed as one of the following diseases: Systemic lupus erythematosus (SLE)；Sjogren's syndrome (SS) ; Systemic Scleroderma (SSc); Dermatomyositis (DM); Anti neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV).
- Patients who have been treated with ≥ 2 immunosuppressive agents for 3 months, or require ≥ 15mg glucocorticoids to maintain stable condition, or are intolerant to standard treatment, or have relative contraindications, and whose disease activity meets the following criteria:
- For SLE patients, SLEDAI ≥ 8 points;
- For SS patients, Sjogren's syndrome disease activity index(ESSDAI )≥ 14 points;
- For SSc patients, the modified Rodnan skin score (mRSS) score ranges from 10 to 35 (including cutoff values) and is associated with interstitial pneumonia (ILD);
Show all 18Show fewer
- For DM patients, diagnosed for at least 1 year;
- For ANCA-AAV patients, Birmingham Vasculitis Activity Score(BVAS) score ≥ 15 and ANCA antibodies.
- Eastern Cooperative Oncology Group(ECOG) 0-1 points;
- The evaluation of important organ functions meets the following conditions:
- Blood count: hemoglobin ≥ 60g/L, platelet count ≥ 30 × 109/L;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 55%, no significant abnormalities observed on electrocardiogram;
- Renal function: estimated glomerular filtration rate(eGFR) ≥ 30 mL/min/1.73m2;
- Liver function: Aspartate Aminotransferase(AST) and Alanine Transaminase(ALT) ≤ 3.0 upper limit of normal(ULN), total bilirubin ≤ 2.0 ULN;
- Pulmonary function: diffusion capacity of the lung for carbon monoxide(DLCO) ≥ 40% expected value; forced vital capacity(FVC) ≥ 50% of expected value;
- Having single or intravenous blood collection standards and no other contraindications for cell collection;
- The urine pregnancy test results of subjects of childbearing age are negative, and they agree to take effective contraceptive measures during the trial period, until one year after infusion;
- The patient or their guardian agrees to participate in this clinical trial and signs an informed consent form, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study.
Who cannot join
- Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;
- Suffering from severe diseases of the heart, liver, lungs, blood system, and endocrine system, the researcher has determined that the risk of participating in the trial is higher than the benefit;
- Active or uncontrollable infections that require systemic treatment within the first week of screening;
- Previously received hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or screened for acute graft-versus-host disease (GVHD) with grade 2 or above in the first two weeks;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the hepatitis B virus(HBV) DNA titer in peripheral blood is greater than the normal reference value; Or hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA titer detection greater than the normal reference range; Or positive for human immunodeficiency virus (HIV) antibodies; Or those who test positive for syphilis; Or positive for cytomegalovirus (CMV) DNA detection;
- Received live vaccine within 4 weeks prior to screening;
Show all 10Show fewer
- Pregnancy test positive individuals;
- Patients with malignant tumors and other malignant diseases before screening, in addition to fully treated cervical cancer in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
- Screening patients who have participated in other clinical trials within the first three months;
- Other researchers believe that it is not suitable to participate in this study.
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
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
guo, +86 0351-2170925, 18835137516@139.com
zhang
About this study
Official title: JY231 Injection for the Treatment of Refractory Autoimmune Diseases (ADs) Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of refractory autoimmune diseases
Read the detailed description
This is a single-center, single-arm. open-treatment clinical study, in this study. approximately 10-20 adult and elderly patients with refractory autoimmune diseases will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of JY231 treatment compared to the results of the subjects\' own previous standard treatment regimens or base data.
- Conditions
- Autoimmune Diseases
- Being tested
- JY231
- Keywords
- 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.
JY231Genetic
Also called Fludarabine, Cyclophosphamide
Infusion of JY231 Injection by dose of 1-10×10^6 TU/kg、 1-5×10^7 TU/kg、5-10 ×10^7 TU/kg Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)
| Study group | Role | What they receive |
|---|---|---|
| JY231 injection for the treatment of refractory autoimmune diseases (ADs) Early exploratory clinica | Experimental | Infusion of JY231 Injection by dose of 1-10×10^6 transducing units(TU)/kg、 1-5×10^7 TU/kg、5-10 ×10^7 TU/kg Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required) Receives: Genetic: JY231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Metric/method of measurement: (2007)《Revised response criteria for malignant lymphoma》
Measured: Day 0、Month 1、Month 2、Month 3、Month 6、Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start8 Feb 2024 (estimated)
- Primary completion31 Dec 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 Autoimmune DiseasesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- liyun zhang, Doctoral, Principal investigator, Shanxi Bethune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243159
- Sponsor's protocol ID
- JY-CT-23-007
- Acronym
- JY231、ADs
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JY231 Injection for the Treatment of Refractory Autoimmune Diseases (ADs) Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy
- ClinicalTrials.gov ID
- NCT06243159
- Acronym / sponsor ID
- JY231、ADs / JY-CT-23-007
- Conditions
- Autoimmune Diseases
- Keywords
- JY231 injection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 8 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Feb 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 refractory autoimmune diseases
Detailed description
This is a single-center, single-arm. open-treatment clinical study, in this study. approximately 10-20 adult and elderly patients with refractory autoimmune diseases will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of JY231 treatment compared to the results of the subjects\' own previous standard treatment regimens or base data.
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 refractory autoimmune diseases (ADs) Early exploratory clinica | Experimental | Genetic: JY231Infusion of JY231 Injection by dose of 1-10×10^6 transducing units(TU)/kg、 1-5×10^7 TU/kg、5-10 ×10^7 TU/kg Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age 18-65 years old, regardless of gender, signed with informed consent (ICF).
- Diagnosed as one of the following diseases: Systemic lupus erythematosus (SLE)；Sjogren's syndrome (SS) ; Systemic Scleroderma (SSc); Dermatomyositis (DM); Anti neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV).
- Patients who have been treated with ≥ 2 immunosuppressive agents for 3 months, or require ≥ 15mg glucocorticoids to maintain stable condition, or are intolerant to standard treatment, or have relative contraindications, and whose disease activity meets the following criteria:
- Eastern Cooperative Oncology Group(ECOG) 0-1 points;
- The evaluation of important organ functions meets the following conditions:
Key exclusion criteria (10 listed)
- Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;
- Suffering from severe diseases of the heart, liver, lungs, blood system, and endocrine system, the researcher has determined that the risk of participating in the trial is higher than the benefit;
- Active or uncontrollable infections that require systemic treatment within the first week of screening;
- Previously received hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or screened for acute graft-versus-host disease (GVHD) with grade 2 or above in the first two weeks;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the hepatitis B virus(HBV) DNA titer in peripheral blood is greater than the normal reference value; Or hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA titer detection greater than the normal reference range; Or positive for human immunodeficiency virus (HIV) antibodies; Or those who test positive for syphilis; Or positive for cytomegalovirus (CMV) DNA detection;
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 |
|---|---|---|
| JY231Also: Fludarabine, CyclophosphamideInfusion of JY231 Injection by dose of 1-10×10^6 TU/kg、 1-5×10^7 TU/kg、5-10 ×10^7 TU/kg Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required) | Genetic | JY231 injection for the treatment of refractory autoimmune diseases (ADs) Early exploratory clinica |
Primary outcome
Objective Response Rate
Time frame: Day 0、Month 1、Month 2、Month 3、Month 6、Month 12
Metric/method of measurement: (2007)《Revised response criteria for malignant lymphoma》
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 6 Feb 2024.
Related trials for Autoimmune Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
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
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.
liyun zhang, Doctoral principal investigator
Shanxi Bethune Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing JY231 in people with Autoimmune Diseases, run by Shanxi Bethune Hospital 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 18 inclusion and 10 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 6 Feb 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Liyun zhang, Doctoral (13834547708, 1315710223@qq.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: Day 0、Month 1、Month 2、Month 3、Month 6、Month 12). 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 6 Feb 2024.