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Starting soon Early Phase 1

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

NCT06485232 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2025-02-28
Last updated
2025-01-01

Condition(s) studied

Neuromyelitis Optica Spectrum DisordersMyasthenia Gravis, GeneralizedMultiple SclerosisChronic Inflammatory Demyelinating Polyradiculoneuropathy

Investigational drug(s) / intervention(s)

Universal BCMA CAR-TUniversal CD19 CAR-TUniversal BCMA CAR-T; Universal CD19 CAR-T

Universal BCMA CAR-T: Universal BCMA CAR-T

Universal CD19 CAR-T: Universal CD19 CAR-T

Universal BCMA CAR-T; Universal CD19 CAR-T: Universal BCMA CAR-T; Universal CD19 CAR-T

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of dose-limiting toxicities(DLTs) — First 28 days after infusion
    Incidence of dose-limiting toxicities(DLTs)
  • Incidence of adverse events(AEs) and severe adverse — Up to 12 months after infusion
    Incidence of adverse events(AEs) and severe adverse events(SAEs).

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06485232 on ClinicalTrials.gov ↗ ← All trials in China