Autoimmune Diseases of the Nervous SystemJY231 NIDNCT06797024
JY231 Injection for the Treatment of Relapsed/Refractory Neurologic Immune Disorders
A study testing JY231 Injection in people with Autoimmune Diseases of the Nervous System, run by Tongji Hospital at 1 site in China.
Trial summary
his study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed/refractory neurologic immune disorders. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Diseases of the Nervous System
- 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
- 28 Feb 2025to 31 Mar 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
- Male or female subjects (both 18 and 75 years of age) aged 18 to 75 years who have signed an informed consent (ICF) that none of the available treatment options have been effective; and
- Previously diagnosed relapsed/refractory neuroimmune disorders for which there are currently no effective treatments, as determined by the specified diagnostic criteria, including:
- Patients with AQP4 antibody-positive optic neuromyelitis optica (NMOSD) who meet the 2015 IPND NMOSD diagnostic criteria and meet one of the following requirements:
- Treatment with at least one immunosuppressive agent for at least one year, or intolerance of immunosuppressive therapy with suboptimal symptom control; At least 2 relapses in the last 12 months or 3 relapses in the last 24 months and at least 1 relapse in the 12 months prior to screening.
- Patients with myasthenia gravis (MG) who meet the 2020 MGFA diagnostic criteria for a total MG-ADL score of ≥6 with a relevant antibody-positive MGFA classification II-IV and meet one of the following requirements:
- Have used standardized treatment with at least one immunosuppressive agent for more than 1 year and have one of the following poorly controlled conditions: 1) persistent weakness that interferes with daily life 2) exacerbation of MG symptoms and/or crisis episodes despite standardized treatment, and 3) inability to tolerate immunosuppressive therapy; Requires plasma exchange or intravenous gammaglobulin maintenance therapy.
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- Patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who meet the 2021 EAN/PNS diagnostic criteria of an INCAT Disability Scale total score of 2-9 positive for relevant antibodies and meet one of the following requirements:
- Standardized use of at least one first-line therapy for more than 3 months (cortisol hormone therapy, gammaglobulin, or plasma exchange therapy) with poor symptom control; Inability to tolerate cortisol hormone, gammaglobulin, and plasma exchange therapy because of side effects or other conditions.
- Patients with a clinical diagnosis of refractory antibody-positive idiopathic inflammatory myopathy who meet the 2017 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for a diagnosis of IIM, with proximal muscle strength of at least one limb less than or equal to grade 4, and elevated creatine kinase. And meet one of the following requirements:
- Presence of at least one creatine enzyme (CK, AST, ALT, ALD, LDH) ≥1.5 x ULN in the screening period; or dermatomyositis with a Dermatologic Lesion Extent and Severity Index (CDASI) ≥6; or evidence of active myositis in at least one of the following: MRI, electromyography, and muscle biopsy within the last 6 months; Presence of at least 1 myositis-specific (MSA), associated antibody (MAA), or antinuclear antibody (ANA) positive; Treatment with corticosteroids for at least 1 month and standardized treatment with at least one immunosuppressant/modulator (e.g., azathioprine, methotrexate, merti-macrolide, cyclosporine, tacrolimus, cyclophosphamide, leflunomide, and intravenous gammaglobulin) for more than 3 months with poor symptom control.
- Inability to tolerate treatment with the above traditional regimens because of side effects or other conditions;
- Clinically confirmed diagnosis of progressive MS (including primary progressive PPMS or secondary progressive SPMS) or relapsing-remitting RMS according to the 2017 Revised McDonald's Diagnostic Criteria; and Disability Status at Screening meets an EDSS score of 2-7, inclusive.RMS subjects will be required to standardize their use of DMT prior to signing the informed consent form medications still have a clear record of meeting the following conditions:
- 2 relapses documented within 2 years prior to screening, or
- 1 relapse documented within 1 year prior to screening, or Positive Gd-enhanced MRI scan within 1 year prior to screening (Screening MRI scan results may be used if no documented positive Gd-enhanced scan results existed in the previous year).
- A clinically confirmed diagnosis of autoimmune encephalitis according to the 2016 International Autoimmune Encephalitis Diagnostic Criteria, along with all of the following requirements:
- Positive test for at least one relevant autoantibody; Poor symptom control or intolerance of previous standardized treatment with glucocorticoids, at least one immunosuppressant/modulator including CD20 monoclonal antibody; Autoimmune encephalitis exacerbation within 3 months prior to signing the informed consent form; Disability status at screening meeting an mRS score of ≥2 or a CASE score of ≥4.
- A clinically confirmed diagnosis of MOGAD according to the 2023 International Diagnostic Criteria for MOGAD, as well as meeting all of the following requirements:
- Positive MOG autoantibody test by CBA method; Disability status at screening meeting an mRS score of ≥2; Poor symptom control or intolerance after prior standardized treatment with glucocorticoids, conventional immunosuppressants/modulators, and at least one biologic agent including CD20 monoclonal antibody.
- 3)ECOG 0 to 1 point; 4)Vital organ function assessment meets the following criteria: Blood: hemoglobin ≥ 60 g/L, platelet count ≥ 30 x 109/L; cardiac function: left ventricular ejection fraction (LVEF) ≥55%, ECG without obvious abnormalities; renal function: eGFR ≥30 ML/min/1.73m2; Liver function: AST and ALT ≤3.0 ULN, total bilirubin ≤2.0 ULN; Lung function: dlco ≥40% of predicted value; fvc ≥50% of predicted value; have criteria for single or venous blood collection and no other contraindications to cell collection; 5)Subjects of childbearing age with negative urine pregnancy test results and agree to use effective contraception for the duration of the trial until 1 year post-infusion; 6)The patient or his/her guardian agrees to participate in the clinical trial and signs the informed consent form, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study.
Who cannot join
- have a contraindication or hypersensitivity to fludarabine, cyclophosphamide, and any component of the test drug;
- have received intravenous immunoglobulin or plasma exchange therapy or immunosorbent therapy within 4 weeks prior to retrieval;
- have used tacrolimus, cyclosporine, azathioprine, morphimecrolimus, mycophenolate mofetil, methotrexate, or methotrexate within 1 week prior to mono-harvesting;
- Treatment with neonatal Fc receptor (FcRn) antagonists (e.g., Efgartigimod, etc.) within 1 week prior to single-take;
- have used complement inhibitory therapy (e.g., eculizumab, etc.) within 1 week prior to single-take;
- Suffering from severe cardiac, hepatic, pulmonary, hematologic, or endocrine system diseases that, in the judgment of the investigator, pose a greater risk than benefit of participation in the trial;
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- Presence of active or uncontrollable infection requiring systemic therapy within 1 week prior to screening;
- Previous hematopoietic stem cell transplantation or solid organ transplantation (except cornea and hair transplantation), or Grade 2 or higher acute graft-versus-host disease (GVHD) within 2 weeks 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 value range; or Hepatitis C Virus (HCV) antibody positive and peripheral blood Hepatitis C Virus (HCV) RNA titer test is greater than the normal reference value 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;
- Positive pregnancy test;
- Patients with malignant diseases such as malignant tumors prior to screening, except adequately treated carcinoma in situ of the cervix, 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 trial within 3 months prior to screening;
- Other conditions that the investigator considers unsuitable for participation in the 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, 1 recruiting
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Chuan Qin, PhD, 86-27-83663337, qinchuan712@126.com
Chuan Qin, MD, 86-27-83663333, chuanqin@tjh.tjmu.edu.cn
About this study
Official title: An Early Exploratory Clinical Study of the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection for the Treatment of Relapsed/Refractory Neurologic Immune Disorders
his study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed/refractory neurologic immune disorders. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed/refractory neurologic immune disorders.
Read the detailed description
This open-label, single-arm study is designed to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with relapsed/refractory neurologic immune disorders. Upon enrolment, leukapheresis will be performed and patients will receive 3-5 days of fludarabine and cyclophosphamide lymphodepleting therapy followed by an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be evaluated for safety and efficacy for up to 24 months to determine if the disease is under control.
- Being tested
- JY231 Injection
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JY231 InjectionDrug
JY231 injection is administered intravenously and produces autologous CAR-T cells in the patient's body some time after infusion. A total of 3 dose groups were established to conduct a 3+3 dose-escalation study. The doses were divided into two categories: non-lymphodepletion and lymphodepletion pretreatment. The three dose groups for lymphodepletion included: 2×10^8 TU, 4×10^8 TU, and 8×10^8 TU. The three dose groups for non-lymphodepletion included: 2×10^9 TU, 4×10^9 TU, and 8×10^9 TU. The decision to perform lymphodepletion was based on the lymphocyte count and function during the patient screening period.
| Study group | Role | What they receive |
|---|---|---|
| JY231 injection for the treatment of relapsed/refractory neurologic immune disorders | Experimental | JY231 Injection for the Treatment of relapsed/refractory neurologic immune disorders subjects who meet the inclusion criteria will receive intravenous JY231. JY231 infusion will produce CAR-T cells in the body. Receives: Drug: JY231 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted28 Jan 2025
- Study start28 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Diseases of the Nervous SystemStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daishi Tian, Tongji Hospital
- Investigators
- Dai-shi Tian, PhD, Principal investigator, Tongji HospitalWei Wang, PhD, Principal investigator, Tongji HospitalChuan Qin, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797024
- Sponsor's protocol ID
- JY-CT-24-004
- Acronym
- JY231 NID
- Status last verified
- May 2025
- First submitted
- 19 Jan 2025
- Last updated
- 31 May 2025
- Results posted
- 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 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Exploratory Clinical Study of the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection for the Treatment of Relapsed/Refractory Neurologic Immune Disorders
- ClinicalTrials.gov ID
- NCT06797024
- Acronym / sponsor ID
- JY231 NID / JY-CT-24-004
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Jan 2025 (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.
his study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed/refractory neurologic immune disorders. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed/refractory neurologic immune disorders.
Detailed description
This open-label, single-arm study is designed to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with relapsed/refractory neurologic immune disorders. Upon enrolment, leukapheresis will be performed and patients will receive 3-5 days of fludarabine and cyclophosphamide lymphodepleting therapy followed by an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be evaluated for safety and efficacy for up to 24 months to determine if the disease is under control.
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 relapsed/refractory neurologic immune disorders | Experimental | Drug: JY231 InjectionJY231 Injection for the Treatment of relapsed/refractory neurologic immune disorders subjects who meet the inclusion criteria will receive intravenous JY231. JY231 infusion will produce CAR-T cells in the body. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female subjects (both 18 and 75 years of age) aged 18 to 75 years who have signed an informed consent (ICF) that none of the available treatment options have been effective; and
- Previously diagnosed relapsed/refractory neuroimmune disorders for which there are currently no effective treatments, as determined by the specified diagnostic criteria, including:
- Patients with AQP4 antibody-positive optic neuromyelitis optica (NMOSD) who meet the 2015 IPND NMOSD diagnostic criteria and meet one of the following requirements:
- Treatment with at least one immunosuppressive agent for at least one year, or intolerance of immunosuppressive therapy with suboptimal symptom control; At least 2 relapses in the last 12 months or 3 relapses in the last 24 months and at least 1 relapse in the 12 months prior to screening.
- Patients with myasthenia gravis (MG) who meet the 2020 MGFA diagnostic criteria for a total MG-ADL score of ≥6 with a relevant antibody-positive MGFA classification II-IV and meet one of the following requirements:
Key exclusion criteria (14 listed)
- have a contraindication or hypersensitivity to fludarabine, cyclophosphamide, and any component of the test drug;
- have received intravenous immunoglobulin or plasma exchange therapy or immunosorbent therapy within 4 weeks prior to retrieval;
- have used tacrolimus, cyclosporine, azathioprine, morphimecrolimus, mycophenolate mofetil, methotrexate, or methotrexate within 1 week prior to mono-harvesting;
- Treatment with neonatal Fc receptor (FcRn) antagonists (e.g., Efgartigimod, etc.) within 1 week prior to single-take;
- have used complement inhibitory therapy (e.g., eculizumab, etc.) within 1 week prior to single-take;
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 InjectionJY231 injection is administered intravenously and produces autologous CAR-T cells in the patient's body some time after infusion. A total of 3 dose groups were established to conduct a 3+3 dose-escalation study. The doses were divided into two categories: non-lymphodepletion and lymphodepletion pretreatment. The three dose groups for lymphodepletion included: 2×10^8 TU, 4×10^8 TU, and 8×10^8 TU. The three dose groups for non-lymphodepletion included: 2×10^9 TU, 4×10^9 TU, and 8×10^9 TU. The decision to perform lymphodepletion was based on the lymphocyte count and function during the patient screening period. | Drug | JY231 injection for the treatment of relapsed/refractory neurologic immune disorders |
Primary outcome
Incidence of adverse events(AE) after infusion
Time frame: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Maximal Tolerated Dose(MTD)
Time frame: Up to 28 days after infusion
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
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 31 May 2025.
- Individual participant dataSharing planned: No
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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.
Dai-shi Tian, PhD principal investigator
Tongji Hospital
Wei Wang, PhD principal investigator
Tongji Hospital
Chuan Qin principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JY231 Injection in people with Autoimmune Diseases of the Nervous System, run by Tongji 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 19 inclusion and 14 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 31 May 2025. 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.
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 Chuan Qin, PhD (+86 138 8605 2650, chuanqin@tjh.tjmu.edu.cn), or a site near the patient. 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?
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 31 May 2025.