Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.
What it found
No result yet.
What was tested
Treatment tested
- Universal BCMA CAR-T
- Universal CD19 CAR-T
- Universal BCMA CAR-T; Universal CD19 CAR-T
What it measured
Main measures
Incidence of dose-limiting toxicities(DLTs)
First 28 days after infusion
SafetyIncidence of adverse events(AEs) and severe adverse
Up to 12 months after infusion
Safety
Other measures (8)
Concentrations of UCAR-T cells
3 months
Immune responseB cell levels in peripheral blood
3 months
Immune responseChanges of pathogenic antibody titers after infusion
1, 3, 6 ,12months
Blood or spinal fluid markersImmune responseNMOSD: Annualized relapse rate
6, 12months
RelapsesgMG: Changes of Myasthenia Gravis Activities if Daily Living (MG-ADL) Score
1, 3, 6, 12months
CIDP:Changes of Inflammatory Neuropathy Cause and Treatment (INCAT) Score after infusion.
1, 3, 6, 12months
Walking and mobilityArm and hand functionMS: Changes of the number of Gd-enhancing T1 Lesions
6, 12months
MRI lesionsMS: Changes of the number of Number of New or Enlarging T2 Lesions
6, 12months
MRI lesions
Who could take part
MS (type not specified) · 18 to 75
Inclusion Criteria: * Aged 18-75 years (for MS patients, 18-55 years); both genders eligible. * Subjects with refractory neurological autoimmune diseases who have failed standard treatment or lack effective treatment, Including neuromyelitis optica spectrum disorders(NMOSD), generalized myasthenia gravis(gMG), chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP) and multiple sclerosis(MS). * Anticipated survival of ≥ 12 weeks as judged by the researcher. * Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication. * Provides written informed consent. Exclusion Criteria: * History of solid organ transplantation. * Malignant tumor within the last two years. * Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis. * Primary immunodeficiency (congenital or acquired). * Severe cardiac disease. * History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal. * Allergic constitution or a history of severe allergies. * Pregnant or breastfeeding women.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Papers
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History
Started
Feb 2025
Main results due
Dec 2026
Finished
Dec 2027
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