Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.
NCT ID: NCT06485232
Last Updated: 2025-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
25 participants
INTERVENTIONAL
2025-02-28
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BCMA CAR-T Group
Universal BCMA CAR-T
Universal BCMA CAR-T
Universal BCMA CAR-T
CD19 CAR-T Group
Universal CD19 CAR-T
Universal CD19 CAR-T
Universal CD19 CAR-T
BCMA CAR-T + CD19 CAR-T Group
Universal BCMA CAR-T; Universal CD19 CAR-T
Universal BCMA CAR-T; Universal CD19 CAR-T
Universal BCMA CAR-T; Universal CD19 CAR-T
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Bioray Laboratories
INDUSTRY
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-BRL-302-02
Identifier Type: -
Identifier Source: org_study_id
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