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Multiple Sclerosis (MS)Phase 1NCT07341828

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

A Phase 1 study testing CD20/BCMA-directed CAR-T cells in people with Multiple Sclerosis (MS) and Neuromyelitis Optica Spectrum Disorders (NMOSD), run by Huashan Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 central nervous system autoimmune diseases refractory to standard therapy Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CD20/BCMA-directed CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Feb 2026to Feb 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xiangjun Chen contact

+86 21 52888159

xiangjchen@fudan.edu.cn

About this study

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

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

Being tested
CD20/BCMA-directed CAR-T cells
Keywords
CD20/BCMA-directed CAR-T cells
Medical subject headings
Multiple Sclerosis, Neuromyelitis Optica, Autoimmune Diseases of the Nervous System, Stiff-Person Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD20/BCMA-directed CAR-T cellsBiological

    Also called C-CAR168

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

Study groups in NCT07341828
Study groupRoleWhat they receive
C-CAR168ExperimentalAutologous C-CAR168 administered by intravenous (IV) infusion
Receives: Biological: CD20/BCMA-directed CAR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Throughout the first 3 months follow up period completion

  2. The subsequent recommended dose of C-CAR168 in patients with central nervous system autoimmune diseases refractory to standard therapy

    Based on the assessment of overall safety profile

    Measured: Throughout the first 24 months follow up period completion

Secondary outcomes (14)

  1. Incidence and severity of adverse events (AE)

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

    Measured: Throughout the first 24 months follow up period completion

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

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

    Measured: Throughout the first 24 months follow up period completion

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

    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).

    Measured: Throughout the first 24 months follow up period completion

  4. MS and NMOSD: MRI

    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

    Measured: Throughout the first 24 months follow up period completion

  5. Autoimmune Encephalitis (AiE): Clinical Assessment Scale in Autoimmune Encephalitis (CASE)

    Change from baseline in CASE at 6 months and 24 months post-infusion. The Clinical Assessment Scale in Autoimmune Encephalitis (CASE) has a score range from 0 to 27, and higher scores indicate a worse clinical outcome.

    Measured: Throughout the first 24 months follow up period completion

  6. MS, NMOSD and AiE: Annualized Relapse Rate (ARR)

    ARR at 6 months and 24 months post-infusion

    Measured: Throughout the first 24 months follow up period completion

  7. Stiff-Person Syndrome (SPS): Distribution of Stiffness Index (DSI)

    Change from baseline in DSI at 6 months and 24 months post-infusion. Distribution of Stiffness Index (DSI) is a validated indicator or stiffness. Scores range from 0 to 6 and reflect the extent of stiffness. Higher scores indicate a worse outcome.

    Measured: Throughout the first 24 months follow up period completion

  8. SPS: Heightened Sensitivity Score (HSS)

    Change from baseline in HSS at 6 months and 24 months post-infusion. Heightened Sensitivity Score (HSS) measures changes in the frequency of spasms. Scores range from 0 to 7. Higher scores indicate a worse outcome.

    Measured: Throughout the first 24 months follow up period completion

  9. Pharmacokinetics (PK): Maximal plasma concentration (Cmax)

    Cmax of C-CAR168 in peripheral blood

    Measured: Throughout the first 24 months follow up period completion

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

    Tmax of C-CAR168 in peripheral blood

    Measured: Throughout the first 24 months follow up period completion

  11. PK: Duration in peripheral blood (Tlast)

    Tlast of C-CAR168 in peripheral blood

    Measured: Throughout the first 24 months follow up period completion

  12. PK: Area under curve (AUC)

    AUC of C-CAR168 in peripheral blood

    Measured: Throughout the first 24 months follow up period completion

  13. Pharmacodynamics (PD): Depletion of peripheral blood B cells, plasma cells, and CD20dim T cells

    Measured: Throughout the first 24 months follow up period completion

  14. PD: Decline of serum immunoglobulin

    Measured: Throughout the first 24 months follow up period completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study startFeb 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07341828
Sponsor's protocol ID
KY2025-1015
Status last verified
Dec 2025
First submitted
6 Jan 2026
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD20/BCMA-directed CAR-T cells in people with Multiple Sclerosis (MS) and Neuromyelitis Optica Spectrum Disorders (NMOSD), run by Huashan Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiangjun Chen (+86 21 52888159, xiangjchen@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of Adverse Events [Safety and Tolerability] (time frame: Throughout the first 3 months follow up period completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07341828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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