Actively Recruiting
Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System
Led by Tongji Hospital · Updated on 2024-10-30
36
Participants Needed
1
Research Sites
348 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
N
Nanjing IASO Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles. In this study, we will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathyand (IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and POEMS Syndrome. B-cell maturation antigen (BCMA) is expressed on the surface of plasma cells, thus making it an ideal target for targeted therapies. Chimeric antigen receptor (CAR) T cells against BCMA offers another potential therapeutic option to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In the current study, the safety and efficacy of a novel CAR-T cell therapy using CT103A cells, are evaluated in patients with relapsed/refractory antibody-mediated idiopathic inflammatory diseases.
CONDITIONS
Official Title
Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18-75 years (including 18 and 75 years)
- Diagnosed with relapsed or refractory antibody-mediated inflammatory diseases of the nervous system without effective treatment, including NMOSD, MG, CIDP, idiopathic inflammatory myopathy, multiple sclerosis, autoimmune encephalitis, MOGAD, and POEMS Syndrome
- Specific diagnostic criteria met for each disease including antibody positivity, clinical relapse history, and disease severity scores
- Poorly controlled symptoms despite standardized immunosuppressant or other treatments, or inability to tolerate such treatments
- Acute toxic reactions resolved to baseline or grade 1 except those deemed safe by investigator
- Satisfactory organ function and lab results including blood counts, liver and kidney function, electrolytes, coagulation tests
- Blood oxygen saturation above 91% at rest
- Echocardiography showing left ventricular ejection fraction 50% or higher
- Expected life expectancy of 12 weeks or more
- Willingness to use effective contraception for one year after CT103A infusion
- Provide written informed consent before study participation
You will not qualify if you...
- Insufficient mononuclear cells for CAR-T manufacturing
- History of autoimmune hemolytic disease or solid organ transplantation
- Recent treatment with alemtuzumab, fludarabine, or cladribine within specified time frames
- Infection with Papovaviruses
- Diagnosis of malignancy within last 2 years except certain low-risk cancers
- Chronic active infections such as hepatitis B, hepatitis C, HIV, cytomegalovirus, or syphilis
- Uncontrolled MG crisis within 2 weeks before enrollment
- Known primary immunodeficiency
- Severe cardiac conditions including unstable angina, recent myocardial infarction, advanced heart failure, or severe arrhythmia
- Recent cerebrovascular accident within 6 months
- Major surgery within 4 weeks before enrollment
- Serious uncontrolled comorbidities that may affect study evaluation
- History of thymectomy within 12 months prior to infusion
- History of psychoactive drug abuse or psychiatric disorders
- History of severe allergies or prone to allergies
- Pregnant or breastfeeding women
- Any other conditions deemed unsuitable by investigator
- Before lymphodepletion and infusion: low neutrophil or platelet counts, need for oxygen to maintain saturation, uncontrolled infections, low creatinine clearance, need for maintenance support treatment, infusion delay over 7 days, or other unsuitable conditions
AI-Screening
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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, MD
CONTACT
C
Chuan Qin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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