Trials / Recruiting
RecruitingNCT06939166
Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune Diseases
A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed / Refractory Neurological Autoimmune Diseases
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Tianjin Huanhu Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.
Detailed description
This is an investigator-initiated trial to evaluate the safety and efficacy of universal CD19/BCMA CAR T-cells in Relapsed or Refractory Neurological Autoimmune Diseases. Study intervention consists of a single infusion of universal CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Interim analysis will be performed when participants finish the visit 90 days after CAR T-cell infusion.
Conditions
- Neuromyelitis Optica Spectrum Disorders
- Myasthenia Gravis
- Multiple Sclerosis
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Autoimmune Encephalitis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | UCAR T-cell | Universal allogeneic anti-CD19/BCMA CAR T-cells |
Timeline
- Start date
- 2025-06-17
- Primary completion
- 2026-04-01
- Completion
- 2027-10-01
- First posted
- 2025-04-22
- Last updated
- 2025-12-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06939166. Inclusion in this directory is not an endorsement.