Actively Recruiting
JY231 Injection for the Treatment of Relapsed/Refractory Neurologic Immune Disorders
Led by Tongji Hospital · Updated on 2025-05-31
20
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
JY231 Injection for the Treatment of Relapsed/Refractory Neurologic Immune Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years who have signed informed consent and for whom available treatments have been ineffective
- Diagnosed with relapsed or refractory neurologic immune disorders meeting specified diagnostic criteria, including:
- AQP4 antibody-positive neuromyelitis optica with prior immunosuppressive treatment or intolerance and recent relapses
- Myasthenia gravis with MG-ADL score 656, relevant antibody positivity, prior immunosuppressive treatment, and poor symptom control
- Chronic inflammatory demyelinating polyneuropathy with relevant antibody positivity and poor response or intolerance to first-line therapies
- Refractory antibody-positive idiopathic inflammatory myopathy with clinical and laboratory criteria, prior corticosteroids and immunosuppressant treatment with poor control
- Progressive or relapsing multiple sclerosis meeting diagnostic criteria and disability status with recent relapses or MRI activity
- Autoimmune encephalitis with positive antibodies, poor symptom control, recent exacerbation, and specified disability scores
- MOG antibody disease with positive test, disability status, and poor control after prior treatments
- ECOG performance status 0 to 1
- Adequate vital organ function based on blood counts, heart, kidney, liver, and lung function tests
- Negative pregnancy test for those of childbearing potential and agreement to use effective contraception
- Willingness to participate and provide informed consent
You will not qualify if you...
- Allergy or contraindication to fludarabine, cyclophosphamide, or components of the study drug
- Use of intravenous immunoglobulin, plasma exchange, or immunosorbent therapy within 4 weeks prior to leukapheresis
- Use of certain immunosuppressants (e.g., tacrolimus, cyclosporine, azathioprine) within 1 week prior to leukapheresis
- Use of neonatal Fc receptor antagonists or complement inhibitory therapy within 1 week prior to leukapheresis
- Severe cardiac, liver, lung, blood, or endocrine diseases posing high risk
- Active or uncontrolled infections requiring systemic therapy within 1 week prior to screening
- Recent hematopoietic stem cell or solid organ transplantation or acute graft-versus-host disease
- Positive tests for hepatitis B or C, HIV, syphilis, or cytomegalovirus with abnormal viral loads
- Receipt of live vaccines within 4 weeks prior to screening
- Positive pregnancy test
- History of malignant tumors except certain treated cancers
- Participation in another clinical trial within 3 months prior to screening
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
C
Chuan Qin, PhD
CONTACT
L
Luo-Qi Zhou, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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