This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Universal BCMA CAR-T
Universal CD19 CAR-T
Universal BCMA CAR-T; Universal CD19 CAR-T
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Incidence of dose-limiting toxicities(DLTs)
Incidence of dose-limiting toxicities(DLTs)
Time frame: First 28 days after infusion
Incidence of adverse events(AEs) and severe adverse
Incidence of adverse events(AEs) and severe adverse events(SAEs).
Time frame: Up to 12 months after infusion
Concentrations of UCAR-T cells
The concentration of BCMA UCAR T cells and CD19 UCAR-T cells in peripheral blood after infusion
Time frame: 3 months
B cell levels in peripheral blood
The change of B cell levels in peripheral blood after infusion
Time frame: 3 months
Changes of pathogenic antibody titers after infusion
The changes of pathogenic antibody titers in peripheral blood or cerebrospinal fluid.
Time frame: 1, 3, 6 ,12months
NMOSD: Annualized relapse rate
ARR is defined as the number of relapses divided by the total participant-years after infusion
Time frame: 6, 12months
gMG: Changes of Myasthenia Gravis Activities if Daily Living (MG-ADL) Score
MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe gMG.
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Time frame: 1, 3, 6, 12months
CIDP:Changes of Inflammatory Neuropathy Cause and Treatment (INCAT) Score after infusion.
The INCAT score assesses the functionality of the arms and legs by giving a 0-5 score for arms and legs, with 0 representing no disability and 5 representing no arm function or inability to stand/walk.
Time frame: 1, 3, 6, 12months
MS: Changes of the number of Gd-enhancing T1 Lesions
The changes of enhancing Lesions as detected by brain Magnetic Resonance Imaging (MRI)
Time frame: 6, 12months
MS: Changes of the number of Number of New or Enlarging T2 Lesions
Number of new/enlarging T2 lesions on last available MRI scan compared to baseline.
Time frame: 6, 12months