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Recruiting 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

Early Phase I Interventional Neuromyelitis Optica Spectrum Disorders Myasthenia Gravis Multiple Sclerosis Chronic Inflammatory Demyelinating Polyradiculoneuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UCAR T-cell.
Who it may be relevant to
Registry conditions: Neuromyelitis Optica Spectrum Disorders, Myasthenia Gravis, Multiple Sclerosis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • The number and severity of dose-limiting toxicity (DLT) events [Time frame: Within 28 Days After UCAR T-cell Infusion]
  • The total number, incidence, and severity of AEs [Time frame: Up to 90 days After UCAR T-cell Infusion]
Secondary outcome measures (6)
  • NMOSD、MS: Expanded Disability Status Scale (EDSS) score [Time frame: Up to 24 Months After UCAR T-cell Infusion]
  • NMOSD、MS: Modified Rankin Scale [Time frame: Up to 24 Months After UCAR T-cell Infusion]
  • MG: Quantitative Myasthenia Gravis Score (QMG) [Time frame: Up to 24 Months After UCAR T-cell Infusion]
  • MG: Myasthenia Gravis Activities if Daily Living (MG-ADL) Score [Time frame: Up to 24 Months After UCAR T-cell Infusion]
  • CIDP: Inflammatory Neuropathy Cause and Treatment (INCAT) Score [Time frame: Up to 24 Months After UCAR T-cell Infusion]
  • AE: Change in CASE [Time frame: Up to 24 Months After UCAR T-cell Infusion]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Huanhu Hospital — Tianjin

Identifiers

NCT: NCT06939166 · QH-HH-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗