Actively Recruiting
A Study of CNCT19 in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases
Led by Juventas Cell Therapy Ltd. · Updated on 2026-03-05
18
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
J
Juventas Cell Therapy Ltd.
Lead Sponsor
B
Beijing Tiantan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-arm, open-label, non-randomized clinical trial aimed at evaluating the safety, tolerability and preliminary efficacy of CNCT19 cell injection in the treatment of patients with relapsed/refractory Neurological Autoimmune Diseases.
CONDITIONS
Official Title
A Study of CNCT19 in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to sign informed consent
- Aged 18 to 75 years, any gender
- Diagnosed with relapsed/refractory antibody-mediated inflammatory neurological diseases with CD19+ B cells
- Meet specific diagnostic criteria and disease activity for one of these: NMOSD, myasthenia gravis, CIDP, multiple sclerosis, autoimmune encephalitis, or MOG antibody-related disease
- Proper organ function based on blood counts, coagulation, liver, kidney, and lung criteria
- Allowed to use low-dose glucocorticoids (prednisone 10mg or equivalent) during the study
- Fertile participants agree to use effective contraception during treatment and for 24 months after
- Female participants of childbearing potential have negative pregnancy tests at screening
You will not qualify if you...
- Current medical or neurological conditions affecting assessment such as dementia, schizophrenia, bipolar disorder, major depression, brain injury, or substance abuse
- Pregnant or breastfeeding
- Prior organ or hematopoietic stem cell transplantation
- Recent thrombosis or organ infarction within 6 months
- Active connective tissue diseases needing non-hormonal immunosuppressants
- Active infections including sepsis, bacteremia, mycosis, uncontrolled pulmonary infections, or tuberculosis
- Positive for hepatitis B, hepatitis C, HIV, syphilis, or with high EBV or CMV viral loads
- Major surgery within 4 weeks before screening
- Malignant tumors within 5 years except low-risk curable tumors
- Significant heart conditions including low ejection fraction, uncontrolled hypertension, severe heart failure, serious arrhythmias, recent heart surgery, or other unsuitable heart diseases
- Received live vaccine within 6 weeks before screening
- Participation in other interventional clinical trials or recent active investigational drug treatments
- Known allergy to study drug components
- Previous CAR-T cell therapy
- Other conditions 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
Beijing Tiantan Hospital
Beijing, China
Actively Recruiting
Research Team
D
Decai Tian
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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