Actively Recruiting
A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed / Refractory Neurological Autoimmune Diseases
Led by Tianjin Huanhu Hospital · Updated on 2025-12-15
12
Participants Needed
1
Research Sites
78 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
Researchers are evaluating the safety and initial effectiveness of universal CD19/BCMA CAR T-cell therapy in adults with relapsed or refractory neurological autoimmune diseases. These diseases include neuromyelitis optica spectrum disorders, myasthenia gravis, multiple sclerosis, autoimmune encephalitis, and chronic inflammatory demyelinating polyradiculoneuropathy. The study is an early phase 1, open-label trial conducted at a single site, focusing on patients whose disease has not responded to previous treatments. The treatment involves a single intravenous infusion of universal CAR T-cells targeting CD19 and BCMA after patients receive a lymphodepleting regimen with fludarabine and cyclophosphamide. The study plans to enroll up to 12 participants and will perform an interim analysis 90 days after the CAR T-cell infusion to evaluate safety and response. Participants will be closely monitored for adverse events and dose-limiting toxicities within 28 and 90 days after infusion. Disability and disease activity will be assessed up to 24 months using various clinical scales depending on the specific neurological condition. Participants must provide informed consent, comply with study procedures, and agree to contraception requirements if applicable. Overall involvement lasts at least two years for ongoing evaluations.
CONDITIONS
Brief 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 NMOSD, MG, MS, AE, or CIDP
- Female participants of childbearing potential and male participants with partners of childbearing potential must use medically approved contraception or abstinence during treatment and for at least 6 months after
- Female participants of childbearing potential must have a negative HCG test within 7 days before enrollment and not be breastfeeding
- Willingness to participate, sign informed consent, comply with study procedures, and cooperate with follow-up
You will not qualify if you...
- History of severe drug allergies or allergic tendencies
- History of malignancy within the past five years
- Insufficient cardiac function
- Positive for hepatitis B surface antigen or core antibody with detectable HBV DNA above detection limit
- Positive for hepatitis C antibody with detectable HCV RNA
- Positive for HIV antibody
- Positive for syphilis testing
- Pregnant women or women planning to conceive
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single infusion with monitoring up to 28 days
Participants receive a lymphodepleting therapy regimen followed by a single infusion of universal CAR T-cells administered intravenously.
1 infusion visit and frequent monitoring visits during the first 28 days
Duration - Up to 24 months
Participants are monitored for safety and efficacy outcomes for up to 24 months after CAR T-cell infusion.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
Tianjin Huanhu Hospital
Tianjin, China
Actively Recruiting
Research Team
J
Jialing Wu
G
Guanen Zhou
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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