Universal Chimeric Antigen Receptor T-Cell (UCAR T-cell) Therapy Targeting CD19/ BCMA(QT-019C) in Patients With r/ r Neurological Autoimmune Diseases
China15 participantsStarted 2026-03
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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 c…
What they're measuring
1
The number and severity of dose-limiting toxicity (DLT) events