Universal Chimeric Antigen Receptor T-Cell (UCAR T-cell) Therapy Targeting CD19/ BCMA(QT-019C) in Patients With r/ r Neurological Autoimmune Diseases

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Huanhu Hospital

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • QT-019C

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators