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Not yet recruiting NCT07341828

A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy

Phase I Interventional Multiple Sclerosis (MS) Neuromyelitis Optica Spectrum Disorders (NMOSD) Autoimmune Encephalitis Stiff Person Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD20/BCMA-directed CAR-T cells.
Who it may be relevant to
Registry conditions: Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorders (NMOSD), Autoimmune Encephalitis, Stiff Person Syndrome. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Exploratory Clinical Study of Anti-CD20/B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy

Overview

This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with central nervous system autoimmune diseases refractory to standard therapy

Interventions

  • Biological CD20/BCMA-directed CAR-T cells
    Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously

Primary outcome measures

  • Incidence and severity of Adverse Events [Safety and Tolerability] [Time frame: Throughout the first 3 months follow up period completion]
  • The subsequent recommended dose of C-CAR168 in patients with central nervous system autoimmune diseases refractory to standard therapy [Time frame: Throughout the first 24 months follow up period completion]
Secondary outcome measures (12)
  • Incidence and severity of adverse events (AE) [Time frame: Throughout the first 24 months follow up period completion]
  • MS: No Evidence of Disease Activity-3 (NEDA-3) [Time frame: Throughout the first 24 months follow up period completion]
  • MS and NMOSD: Expanded Disability Status Scale (EDSS) [Time frame: Throughout the first 24 months follow up period completion]
  • MS and NMOSD: MRI [Time frame: Throughout the first 24 months follow up period completion]
  • Autoimmune Encephalitis (AiE): Clinical Assessment Scale in Autoimmune Encephalitis (CASE) [Time frame: Throughout the first 24 months follow up period completion]
  • MS, NMOSD and AiE: Annualized Relapse Rate (ARR) [Time frame: Throughout the first 24 months follow up period completion]
  • Stiff-Person Syndrome (SPS): Distribution of Stiffness Index (DSI) [Time frame: Throughout the first 24 months follow up period completion]
  • SPS: Heightened Sensitivity Score (HSS) [Time frame: Throughout the first 24 months follow up period completion]
  • Pharmacokinetics (PK): Maximal plasma concentration (Cmax) [Time frame: Throughout the first 24 months follow up period completion]
  • PK: Time to reach the maximal plasma concentration (Tmax) [Time frame: Throughout the first 24 months follow up period completion]
  • PK: Duration in peripheral blood (Tlast) [Time frame: Throughout the first 24 months follow up period completion]
  • PK: Area under curve (AUC) [Time frame: Throughout the first 24 months follow up period completion]

Eligibility criteria

Inclusion criteria

  • 18 to 70 years old at the time of signing the Informed Consent Form (ICF).
  • Diagnosed as Multiple Sclerosis (MS)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Autoimmune Encephalitis(AiE)/Stiff Person Spectrum Disorder(SPSD) according to recognized diagnostic criteria for at least 6 months.
  • Prior treatment failure with standard therapy.
  • Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.

Exclusion criteria

  • Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.
  • Uncontrolled active infection.
  • Live vaccine injection within 4 weeks prior to signing the ICF.
  • Major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history.
  • Severe cardiovascular diseases within the past 6 months prior to screening.
  • A history of ≥ Grade 2 bleeding within 4 weeks prior to screening, or requiring long-term anticoagulants treatment.
  • Inadequate washing time for previous treatment.
  • Previously treated with CAR-T cell products or genetically modified T cell therapies.
  • Pregnant or lactating women.
  • Severe central nervous system diseases or pathological changes.
  • Malignancy history within 5 years prior to signing the ICF.
  • Any contraindication to lumbar puncture.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07341828 · KY2025-1015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗