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

NCT07676266 | Not Yet Recruiting Phase 1

• 1 other identifier: 1141-049
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Multiple Sclerosis (MS); Myasthenia Gravis (MG); Neuromyelitis Optica Spectrum Disorder; Systemic Lupus Erythematosus; Systemic Sclerosis; Immune-Mediated Necrotizing Myopathy

Keywords

CD20/BCMA-directed CAR-T cells

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of Adverse Events [Safety and Tolerability]

  Incidence and severity of adverse events (AE) and serious adverse events (SAE) within three months following infusion

  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

  Based on the assessment of overall safety profile

  Throughout the first 24 months follow up period completion

Secondary Outcomes (20)

• Incidence and severity of adverse events (AE)

  Throughout the first 24 months follow up period completion

• MS: No Evidence of Disease Activity-3 (NEDA-3)

  Throughout the first 24 months follow up period completion

• MS and NMOSD: Expanded Disability Status Scale (EDSS)

  Throughout the first 24 months follow up period completion

• MS and NMOSD: MRI

  Throughout the first 24 months follow up period completion

• MS and NMOSD: Annualized Relapse Rate (ARR)

  Throughout the first 24 months follow up period completion

Other Outcomes (3)

• Serum cytokines changes

  Throughout the first 24 months follow up period completion

• Soluble BCMA changes in peripheral blood

  Throughout the first 24 months follow up period completion

• Changes in CSF CAR DNA copy number and CAR-T cells

  Throughout the first 24 months follow up period completion

Study Arms (1)

C-CAR168 Autologous C-CAR168 administered by intravenous (IV) infusion

EXPERIMENTAL

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

Interventions

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

CD20/BCMA-directed CAR-T cells, single infusion intravenously

Also known as: C-CAR168

C-CAR168 Autologous C-CAR168 administered by intravenous (IV) infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• Shanghai AbelZeta Ltd.: collaborator

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Qindao, Shandong, 266003, China

Location

MeSH Terms

Conditions

Multiple Sclerosis; Myasthenia Gravis; Neuromyelitis Optica; Lupus Erythematosus, Systemic; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating 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; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Min Liu, MD

CONTACT

17853297267; liumin1968@yeah.net

Bin Liu, MD

CONTACT

18661806287; Binliu72314@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)