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NCT Number: NCT07676266

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

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

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Connective Tissue Diseases Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Immune-Mediated Necrotizing Myopathy Lupus Erythematosus, Systemic Multiple Sclerosis Myasthenia Gravis Myasthenia Gravis (MG) Myelitis, Transverse Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Optic Nerve Diseases Optic Neuritis Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Systemic Lupus Erythematosus Systemic Sclerosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

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

Other names: C-CAR168

Primary outcomes

  1. Incidence and severity of Adverse Events [Safety and Tolerability]

    Time frame: 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

  2. 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

    Based on the assessment of overall safety profile

Secondary outcomes

  1. Incidence and severity of adverse events (AE)

    Time frame: Throughout the first 24 months follow up period completion

    Incidence and severity of adverse events (AE) and serious adverse events (SAE) during the study

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

    Time frame: Throughout the first 24 months follow up period completion

    Proportion of participants achieving NEDA-3 at 6 months post-infusion and during the study period

  3. MS and NMOSD: Expanded Disability Status Scale (EDSS)

    Time frame: Throughout the first 24 months follow up period completion

    Change from baseline in EDSS at 6 months and 24 months post-infusion. EDSS and its associated functional system(FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death).

  4. MS and NMOSD: MRI

    Time frame: Throughout the first 24 months follow up period completion

    Number of T1 gadolinium-enhancing lesions and new or enlarging T2 lesions, as well as their change from baseline,at 6 months and 24 months post-infusion. Change from baseline in total T2 lesion volume, gray matter volume (GMV),white matter volume (WMV), and brain volume (BV), as well as annualized-brain volume loss (a-BVL), at 6 months and 24 months post-infusion

  5. MS and NMOSD: Annualized Relapse Rate (ARR)

    Time frame: Throughout the first 24 months follow up period completion

    ARR at 6 months and 24 months post-infusion

  6. MG: Minimal Symptom Expression (MSE) and Minimal Clinically Important Difference (MCID)

    Time frame: Throughout the first 24 months follow up period completion

    Proportion of participants achieving MSE or MCID at 6 months and 24 months post-infusion

  7. MG: Quantitative Myasthenia Gravis Score (QMGS)

    Time frame: Throughout the first 24 months follow up period completion

    Change from baseline in QMGS at 6 months and 24 months post-infusion. The Quantitative Myasthenia Gravis Score (QMGS) has a score range from 0 to 39, and higher scores indicate a worse clinical outcome.

  8. MG: Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale

    Time frame: Throughout the first 24 months follow up period completion

    Change from baseline in MG-ADL at 6 months and 24 months post-infusion. The Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale has a score range from 0 to 24, and higher scores indicate a worse clinical outcome.

  9. 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

    Proportion of participants achieving DORIS or LLDAS or SRI-4 at 6 months post-infusion and during the study period

  10. SLE: Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),

    Time frame: Throughout the first 24 months follow up period completion

    Change from baseline in SLEDAI-2K at 6 months and 24 months post-infusion. SLEDAI-2K is a validated global disease-activity index that quantifies SLE activity by rating the presence of 24 weighted clinical and laboratory descriptors across 9 organ systems (central nervous/visual, vascular, renal, musculoskeletal, cutaneous, mucosal/serosal, constitutional, and immunologic/hematologic) occurring within the prior 10 days. Each descriptor is credited only if attributable to active lupus (not infection, drug effect, metabolic cause, or unrelated comorbidity); descriptors are summed for a total score range 0-105, with higher scores indicating greater disease activity.

  11. IMNM: Definition Of Improvement (DOI)

    Time frame: Throughout the first 24 months follow up period completion

    Proportion of participants achieving DOI at 6 months post-infusion and during the study period

  12. IMNM: Manual Muscle Test (MMT)

    Time frame: Throughout the first 24 months follow up period completion

    Change from baseline in MMT at 6 months and 24 months post-infusion. MMT scale is a foundational, internationally recognized clinical tool for quantifying voluntary skeletal muscle strength in patients with neurologic and systemic diseases.

  13. SSc: Revised Composite Response Index in Systemic Sclerosis (r-CRISS)

    Time frame: Throughout the first 24 months follow up period completion

    Proportion of participants achieving r-CRISS at 6 months post-infusion and during the

  14. SSc: modified Rodnan Skin Score (mRSS), FVC%

    Time frame: Throughout the first 24 months follow up period completion

    Change from baseline in mRSS and FVC% at 6 months and 24 months post-infusion. mRSS is the international standard semi quantitative measure of skin thickening in SSc. Scores are summed for a total range of 0-51, with higher scores indicating greater skin involvement.

  15. PK：Maximal plasma concentration (Cmax)

    Time frame: Throughout the first 24 months follow up period completion

    Cmax of C-CAR168 in peripheral blood

  16. PK: Time to reach the maximal plasma concentration (Tmax)

    Time frame: Throughout the first 24 months follow up period completion

    Tmax of C-CAR168 in peripheral blood

  17. PK: Duration in peripheral blood (Tlast)

    Time frame: Throughout the first 24 months follow up period completion

    Tlast of C-CAR168 in peripheral blood

  18. PK: Area under curve (AUC)

    Time frame: Throughout the first 24 months follow up period completion

    AUC of C-CAR168 in peripheral blood

  19. PD: Depletion of peripheral blood B cells, plasma cells, and CD20dim T cells

    Time frame: Throughout the first 24 months follow up period completion

  20. PD: Decline of serum immunoglobulin

    Time frame: Throughout the first 24 months follow up period completion

Other outcomes

  1. Serum cytokines changes

    Time frame: Throughout the first 24 months follow up period completion

    Detection of serum cytokines changes over time by flow cytometry

  2. Soluble BCMA changes in peripheral blood

    Time frame: Throughout the first 24 months follow up period completion

    Detection of soluble BCMA changes in peripheral blood by Enzyme Linked ImmunoSorbent Assay (ELISA)

  3. Changes in CSF CAR DNA copy number and CAR-T cells

    Time frame: Throughout the first 24 months follow up period completion

    Detection of changes in CSF CAR DNA copy number and CAR-T cells by quantitative polymerase chain reaction (qPCR) and flow cytometry

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Liu, MD

CONTACT

[email protected]

18661806287 ext. 053282919030

Min Liu, MD

CONTACT

[email protected]

17853297267

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Collaborators

  • Shanghai AbelZeta Ltd.

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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