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

NCT07392528 | Not Yet Recruiting Early Phase 1

• 1 other identifier: QH-HH-03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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）.

Conditions

Neuromyelitis Optica Spectrum Disorders; Multiple Sclerosis; Myasthenia Gravis

Keywords

Universal Allogeneic CAR T-cells; QT-019C

Outcome Measures

Primary Outcomes (2)

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

  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.

  Within 28 Days After QT-019C Infusion

• The total number, incidence, and severity of AEs

  Up to 90 days After QT-019C Infusion

Secondary Outcomes (6)

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

  Up to 24 Months After QT-019C Infusion

• 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

Study Arms (1)

QT-019C

EXPERIMENTAL

Universal allogeneic CD19/BCMA CAR T-cells

Drug: QT-019C

Interventions

QT-019C DRUG

Universal allogeneic anti-CD19/BCMA CAR T-cells

QT-019C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Neuromyelitis Optica; Multiple Sclerosis; Myasthenia Gravis

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases

Central Study Contacts

Jialing Wu

CONTACT

18622271026; wywjl2009@hotmail.com

Guanen Zhou

CONTACT

86-13920273016; tjzge@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

CN (1)