Clinical trial · Interventional
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
NCT06485232CI-TRIAL-00084260not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Inflammatory Demyelinating Polyradiculoneuropathy | — | UNRESOLVED | — |
| Multiple Sclerosis | — | UNRESOLVED | — |
| Myasthenia Gravis, Generalized | — | UNRESOLVED | — |
| Neuromyelitis Optica Spectrum Disorders | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Universal BCMA CAR-T | Drug | — | UNRESOLVED |
| Universal BCMA CAR-T; Universal CD19 CAR-T | Drug | — | UNRESOLVED |
| Universal CD19 CAR-T | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- BCMA CAR-T Group
- description
- Universal BCMA CAR-T
- interventionNames
- Drug: Universal BCMA CAR-T
- type
- EXPERIMENTAL
- label
- CD19 CAR-T Group
- description
- Universal CD19 CAR-T
- interventionNames
- Drug: Universal CD19 CAR-T
- type
- EXPERIMENTAL
- label
- BCMA CAR-T + CD19 CAR-T Group
- description
- Universal BCMA CAR-T; Universal CD19 CAR-T
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.