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Trial Title:
Universal CAR-T Cells in Patients With Refractory Autoimmune Diseases of the Nervous System.
NCT ID:
NCT06485232
Condition:
Neuromyelitis Optica Spectrum Disorders
Myasthenia Gravis, Generalized
Multiple Sclerosis
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Conditions: Official terms:
Myasthenia Gravis
Multiple Sclerosis
Neuromyelitis Optica
Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Sclerosis
Conditions: Keywords:
universal CAR-T
Neuromyelitis Optica Spectrum Disorders
Myasthenia Gravis
Multiple Sclerosis
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Universal BCMA CAR-T
Description:
Universal BCMA CAR-T
Arm group label:
BCMA CAR-T Group
Intervention type:
Drug
Intervention name:
Universal CD19 CAR-T
Description:
Universal CD19 CAR-T
Arm group label:
CD19 CAR-T Group
Intervention type:
Drug
Intervention name:
Universal BCMA CAR-T; Universal CD19 CAR-T
Description:
Universal BCMA CAR-T; Universal CD19 CAR-T
Arm group label:
BCMA CAR-T + CD19 CAR-T Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xuanwu Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100053
Country:
China
Contact:
Last name:
Junwei Hao, MD; PhD
Phone:
01083198277
Email:
haojunwei@vip.163.com
Start date:
August 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Xuanwu Hospital, Beijing
Agency class:
Other
Collaborator:
Agency:
Bioray Laboratories
Agency class:
Industry
Source:
Xuanwu Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06485232
