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Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System. | Clinical Trials | Clareo Health

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

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

NCT06485232•Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

February 28, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

January 1, 2025

Enrollment

ESTIMATED participants

Conditions

Neuromyelitis Optica Spectrum DisordersMyasthenia Gravis, GeneralizedMultiple SclerosisChronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

Universal BCMA CAR-T

DRUG

Universal CD19 CAR-T

DRUG

Universal BCMA CAR-T; Universal CD19 CAR-T

DRUG

Contacts

Junwei Hao, MD;PhD

CONTACT

01083198277 haojunwei@vip.163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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