Menu
Not yet recruiting NCT06485232

Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.

Early Phase I Interventional Neuromyelitis Optica Spectrum Disorders Myasthenia Gravis, Generalized Multiple Sclerosis Chronic Inflammatory Demyelinating Polyradiculoneuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Universal BCMA CAR-T, Universal CD19 CAR-T, Universal BCMA CAR-T; Universal CD19 CAR-T.
Who it may be relevant to
Registry conditions: Neuromyelitis Optica Spectrum Disorders, Myasthenia Gravis, Generalized, Multiple Sclerosis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Exploratory Study on the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 in the Treatment of Refractory Autoimmune Diseases of the Nervous System

Overview

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.

Interventions

  • Drug Universal BCMA CAR-T
    Universal BCMA CAR-T
  • Drug Universal CD19 CAR-T
    Universal CD19 CAR-T
  • Drug Universal BCMA CAR-T; Universal CD19 CAR-T
    Universal BCMA CAR-T; Universal CD19 CAR-T

Primary outcome measures

  • Incidence of dose-limiting toxicities(DLTs) [Time frame: First 28 days after infusion]
  • Incidence of adverse events(AEs) and severe adverse [Time frame: Up to 12 months after infusion]
Secondary outcome measures (8)
  • Concentrations of UCAR-T cells [Time frame: 3 months]
  • B cell levels in peripheral blood [Time frame: 3 months]
  • Changes of pathogenic antibody titers after infusion [Time frame: 1, 3, 6 ,12months]
  • NMOSD: Annualized relapse rate [Time frame: 6, 12months]
  • gMG: Changes of Myasthenia Gravis Activities if Daily Living (MG-ADL) Score [Time frame: 1, 3, 6, 12months]
  • CIDP:Changes of Inflammatory Neuropathy Cause and Treatment (INCAT) Score after infusion. [Time frame: 1, 3, 6, 12months]
  • MS: Changes of the number of Gd-enhancing T1 Lesions [Time frame: 6, 12months]
  • MS: Changes of the number of Number of New or Enlarging T2 Lesions [Time frame: 6, 12months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Xuanwu Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06485232 · 2024-BRL-302-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗