Actively Recruiting
Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune Diseases
Led by Tianjin Huanhu Hospital · Updated on 2025-12-15
12
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
Sponsors
T
Tianjin Huanhu Hospital
Lead Sponsor
S
Shanghai Xiniao Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.
CONDITIONS
Official Title
Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Positive B cell CD19 or BCMA detected by flow cytometry in peripheral blood
- Diagnosis of relapsed or refractory neurological autoimmune diseases including neuromyelitis optica spectrum disorders, myasthenia gravis, multiple sclerosis, autoimmune encephalitis, or chronic inflammatory demyelinating polyradiculoneuropathy
- Female participants of childbearing potential and male partners must use approved contraception or abstinence during treatment and for 6 months after
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before enrollment and not be breastfeeding
- Willingness to participate, sign informed consent, comply with study requirements, and cooperate with follow-up
You will not qualify if you...
- History of severe drug allergies or allergic tendencies
- History of cancer within the past five years
- Insufficient heart function
- Positive for hepatitis B surface antigen or core antibody with detectable HBV DNA, positive for hepatitis C antibody with detectable HCV RNA, or positive for HIV or syphilis tests
- Pregnant women or women planning to conceive
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Huanhu Hospital
Tianjin, China
Actively Recruiting
Research Team
J
Jialing Wu
CONTACT
G
Guanen Zhou
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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