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Not yet recruiting NCT07676266

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

Phase I Interventional Multiple Sclerosis (MS) Myasthenia Gravis (MG) Neuromyelitis Optica Spectrum Disorder Systemic Lupus Erythematosus

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 Autologous 2nd generation.
Who it may be relevant to
Registry conditions: Multiple Sclerosis (MS), Myasthenia Gravis (MG), Neuromyelitis Optica Spectrum Disorder, Systemic Lupus Erythematosus. 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
China
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 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 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 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]
  • MS and NMOSD: Annualized Relapse Rate (ARR) [Time frame: Throughout the first 24 months follow up period completion]
  • MG: Minimal Symptom Expression (MSE) and Minimal Clinically Important Difference (MCID) [Time frame: Throughout the first 24 months follow up period completion]
  • MG: Quantitative Myasthenia Gravis Score (QMGS) [Time frame: Throughout the first 24 months follow up period completion]
  • MG: Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale [Time frame: Throughout the first 24 months follow up period completion]
  • SLE: Definition Of Remission In SLE (DORIS), Lupus Low Disease Activity State (LLDAS), Systemic Lupus Erythematosus Responder Index-4 (SRI-4) [Time frame: Throughout the first 24 months follow up period completion]
  • SLE: Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K), [Time frame: Throughout the first 24 months follow up period completion]
  • IMNM: Definition Of Improvement (DOI) [Time frame: Throughout the first 24 months follow up period completion]
  • IMNM: Manual Muscle Test (MMT) [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)/Myasthenia Gravis (MG)/Systemic Lupus Erythematosus (SLE)/ Systemic Sclerosis (SSc)/ Immune-Mediated Necrotizing Myopathy (IMNM) 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 for MS or NMOSD.

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

China · 1 center
  • The Affiliated Hospital of Qingdao University — Qingdao

Identifiers

NCT: NCT07676266 · 1141-049

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗