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

NCT06939166 | Recruiting Early Phase 1

• 1 other identifier: QH-HH-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Autoimmune Encephalitis; Neuromyelitis Optica Spectrum Disorders; Myasthenia Gravis

Keywords

Universal Allogeneic CAR T-cells

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 UCAR T-cell Infusion

• The total number, incidence, and severity of AEs

  Up to 90 days After UCAR T-cell Infusion

Secondary Outcomes (6)

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

  Up to 24 Months After UCAR T-cell Infusion

• NMOSD、MS: Modified Rankin Scale

  Up to 24 Months After UCAR T-cell Infusion

• MG: Quantitative Myasthenia Gravis Score (QMG)

  Up to 24 Months After UCAR T-cell Infusion

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

  Up to 24 Months After UCAR T-cell Infusion

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

  Up to 24 Months After UCAR T-cell Infusion

Study Arms (1)

UCAR T-cell group

EXPERIMENTAL

Universal allogeneic CD19/BCMA CAR T-cells

Drug: UCAR T-cell

Interventions

UCAR T-cell DRUG

Universal allogeneic anti-CD19/BCMA CAR T-cells

UCAR T-cell group

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead
• Shanghai Xiniao Biotech Co., Ltd.: collaborator

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Neuromyelitis Optica; Myasthenia Gravis; Multiple Sclerosis; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; 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; Polyradiculoneuropathy; Polyneuropathies; Peripheral Nervous System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jialing Wu

CONTACT

86-18622271026; 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: April 6, 2025
• First Posted: April 22, 2025
• Study Start: June 17, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (1)