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Clinical Trials in China / NCT07676266
Starting soon Phase 1

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

NCT07676266 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Hospital of Qingdao University
Phase
Phase 1
Started
2026-07
Last updated
2026-06-30

Condition(s) studied

Multiple Sclerosis (MS)Myasthenia Gravis (MG)Neuromyelitis Optica Spectrum DisorderSystemic Lupus ErythematosusSystemic SclerosisImmune-Mediated Necrotizing Myopathy

Investigational drug(s) / intervention(s)

CD20/BCMA-directed CAR-T cells Autologous 2nd generation

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence and severity of Adverse Events [Safety and Tolerability] — Throughout the first 3 months follow up period completion
    Incidence and severity of adverse events (AE) and serious adverse events (SAE) within three months following infusion
  • The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy — Throughout the first 24 months follow up period completion
    Based on the assessment of overall safety profile

Trial sites (1)

FacilityCityRegionStatus
The Affiliated Hospital of Qingdao University Qingdao Qindao, Shandong

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Other trials for the same condition

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) Active, not recruiting
A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Relapsing/Refractory Multiple Sclerosis Starting soon
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus Recruiting
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases Starting soon
Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07676266 on ClinicalTrials.gov ↗ ← All trials in China