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NCT Number: NCT06939166

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

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.

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Key information

Conditions

Neuromyelitis Optica Spectrum Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Autoimmune Encephalitis Chronic Disease Chronic Inflammatory Demyelinating Polyradiculoneuropathy Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Eye Diseases Immune System Diseases Multiple Sclerosis Myasthenia Gravis Myelitis, Transverse Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.
  • Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP).
  • Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.
  • Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.

Exclusion criteria

  • Subjects with a history of severe drug allergies or allergic tendencies.
  • History of malignancy within five years.
  • Subjects with insufficient cardiac function.
  • Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA >the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.
  • Pregnant women or women planning to conceive.

Treatment and study plan

UCAR T-cell

Drug

Universal allogeneic anti-CD19/BCMA CAR T-cells

Primary outcomes

  1. The number and severity of dose-limiting toxicity (DLT) events

    Time frame: Within 28 Days After UCAR T-cell Infusion

    DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.

  2. The total number, incidence, and severity of AEs

    Time frame: Up to 90 days After UCAR T-cell Infusion

Secondary outcomes

  1. NMOSD、MS: Expanded Disability Status Scale (EDSS) score

    Time frame: Up to 24 Months After UCAR T-cell Infusion

    EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.

  2. NMOSD、MS: Modified Rankin Scale

    Time frame: Up to 24 Months After UCAR T-cell Infusion

    Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to 6.

  3. MG: Quantitative Myasthenia Gravis Score (QMG)

    Time frame: Up to 24 Months After UCAR T-cell Infusion

    The QMG score is a 13-item scale used to quantify disease severity in myasthenia gravis. The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits).

  4. MG: Myasthenia Gravis Activities if Daily Living (MG-ADL) Score

    Time frame: Up to 24 Months After UCAR T-cell Infusion

    The MG-ADL is an eight-question survey of symptom severity, with each response graded from 0 (normal) to 3 (most severe). Two questions concern ocular, three oropharyngeal, one respiratory, and two extremity functions. Cumulative MG-ADL scores range from 0 to 24

  5. CIDP: Inflammatory Neuropathy Cause and Treatment (INCAT) Score

    Time frame: Up to 24 Months After UCAR T-cell Infusion

    The INCAT score comprises two parts, the arm score and the leg score. Based on a patient's level of impairment in their arms and legs, each part is scored between 0 and 5 points, resulting in an INCAT total score between 0 and 10.

  6. AE: Change in CASE

    Time frame: Up to 24 Months After UCAR T-cell Infusion

    The changes of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score from baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Guanen Zhou

CONTACT

[email protected]

86-13920273016

Jialing Wu

CONTACT

[email protected]

86-18622271026

Sponsors and collaborators

Lead sponsor

Tianjin Huanhu Hospital

Other

Collaborators

  • Shanghai Xiniao Biotech Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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