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

Sponsor
Tianjin Huanhu Hospital
Study ID
NCT06939166
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Autoimmune Encephalitis
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Multiple Sclerosis
  • Myasthenia Gravis
  • Neuromyelitis Optica Spectrum Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UCAR T-cell — DRUG
    Universal allogeneic anti-CD19/BCMA CAR T-cells

Study Details

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.

Key Dates

First listed
Apr 22, 2025
Start date
Jun 17, 2025
Status verified
Dec 2025
Primary completion
Apr 30, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: UCAR T-cell group
    Universal allogeneic CD19/BCMA CAR T-cells

Primary Outcome Measure

The number and severity of dose-limiting toxicity (DLT) events [ Time Frame: Within 28 Days After UCAR T-cell Infusion ]

Central Contacts

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