Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targe

A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA（QT-019C） in Patients With Relapsed / Refractory Neurological Autoimmune Diseases

Not yet recruitingEarly phase 1MS (type not specified)NCT07392528

What it found

Still running

No result yet.

What was tested

Treatment tested

  • QT-019C

What it measured

Main measures

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

    Within 28 Days After QT-019C Infusion

    Immune responseSafety

  • The total number, incidence, and severity of AEs

    Up to 90 days After QT-019C Infusion

Other measures (6)

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

    Up to 24 Months After QT-019C Infusion

    Disability progressionBladder, bowel and sexual function

  • NMOSD、MS: Modified Rankin Scale

    Up to 24 Months After QT-019C Infusion

  • MG: Quantitative Myasthenia Gravis Score (QMG)

    Up to 24 Months After QT-019C Infusion

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

    Up to 24 Months After QT-019C Infusion

  • CIDP: Inflammatory Neuropathy Cause and Treatment (INCAT) Score

    Up to 24 Months After QT-019C Infusion

  • AE: Change in CASE

    Up to 24 Months After QT-019C Infusion

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Age ≥ 18 years. * 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. The following conditions are excluded: non-melanoma skin cancer, stage I tumors that have a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown on smear, stable papillary thyroid carcinoma or follicular thyroid carcinoma. * 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

This is an open label, single-site, dose-escalation study in up to 15 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（QT-019C）.

Loading reviews and guidelines…

History

    1. Started

      Mar 2026

    2. Main results due

      Jun 2027

    3. Finished

      Dec 2028

    Assembled by software from public sources.