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Systemic Lupus Erythematosus (SLE)Phase 1CAR-AIDNCT06249438

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

A Phase 1 study testing CD20/BCMA-directed CAR-T cells in people with Systemic Lupus Erythematosus (SLE) and Immune-mediated Necrotizing Myopathy (IMNM), run by RenJi Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an investigator-initiated, multicenter, 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 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
30 participants
Where
1 siteChina
Study dates
20 Mar 2024to Mar 2040
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 SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG)/Systemic Sclerosis (SSc) according to recognized diagnostic criteria for at least 6 months.
  • Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated with at least two immunosuppressants (including immunosuppressants, biologics, and disease-modifying drug (DMD) ).
  • 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.
  • ≥ Grade 2 bleeding within the past 30 days prior to screening, or requiring long-term anticoagulants treatment.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nan Shen, MD & PhD contact

+86-21-63260477

nanshensibs@gmail.com

Huihua Ding, MD contact

+86-21-53882280

dinghuihua@outlook.com

China1 site, 1 recruiting

  • Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University

    Shanghai, Shanghai Municipality, 200001

    Nan Shen, MD & PhD, +86-21-63260477, nanshensibs@gmail.com

    Huihua Ding, MD, +86-21-53882280, dinghuihua@outlook.com

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study of Cluster of Differentiation Antigen 20(CD20)/Anti-B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

This is an investigator-initiated, multicenter, 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

Being tested
CD20/BCMA-directed CAR-T cells
Keywords
CD20/BCMA-directed CAR-T cells
Medical subject headings
Lupus Erythematosus, Systemic, Neuromyelitis Optica, Multiple Sclerosis, Myasthenia Gravis, Scleroderma, Systemic

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 NCT06249438
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 of Adverse Events [Safety and Tolerability]

    Incidence of any adverse events (AEs), including dose limiting toxicities (DLTs)

    Measured: Throughout the first 24 months follow up period completion (3 years)，DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion

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

    Based on the assessment of dose-limiting toxicities (DLTs) rates and overall safety profile

    Measured: Throughout the first 24 months follow up period completion (3 years)

Secondary outcomes (14)

  1. The proportion of subjects who achieved remission at 6 months (6M)

    Measured: Throughout the first 6 months follow up period completion (1.5 years)

  2. The proportion of subjects who achieved remission during the main study period

    Measured: Throughout the first 24 months follow up period completion (3 years)

  3. The proportion of subjects who experienced relapse during the main study period

    Measured: Throughout the first 24 months follow up period completion (3 years)

  4. Time to response (TTR)

    The time from the date of C-CAR168 infusion to the first documented remission

    Measured: Throughout the first 24 months follow up period completion (3 years)

  5. Progression-free survival (PFS)

    The time from the date of C-CAR168 infusion to the date of first documented disease progression or death, whichever comes first

    Measured: Throughout the first 24 months follow up period completion (3 years)

  6. The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period

    Measured: Throughout the first 24 months follow up period completion (3 years)

  7. Maximal plasma concentration (Cmax)

    Maximal plasma concentration of C-CAR168 in peripheral blood

    Measured: Throughout the first 24 months follow up period completion (3 years)

  8. Time to reach the maximal plasma concentration (Tmax)

    Time to reach the maximal plasma concentration of C-CAR168 in peripheral blood

    Measured: Throughout the first 24 months follow up period completion (3 years)

  9. Duration in peripheral blood (Tlast)

    The duration of C-CAR168 in peripheral blood

    Measured: Throughout the first 24 months follow up period completion (3 years)

  10. Area under curve (AUC)

    Area under the curve of C-CAR168 in peripheral blood

    Measured: Throughout the first 24 months follow up period completion (3 years)

  11. The clearance of peripheral blood B cell

    Measured: Throughout the first 24 months follow up period completion (3 years)

  12. The decline of serum immunoglobulin

    Measured: Throughout the first 24 months follow up period completion (3 years)

  13. The elevation of peripheral blood complement

    Measured: Throughout the first 24 months follow up period completion (3 years)

  14. The decline of autoantibodies or other disease specific biomarkers

    Measured: Throughout the first 24 months follow up period completion (3 years)

Timeline

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

  1. First posted8 Feb 2024
  2. Study start20 Mar 2024
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2040 (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
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06249438
Sponsor's protocol ID
1141-043(CAR-AID)
Acronym
CAR-AID
Status last verified
Jul 2025
First submitted
21 Jan 2024
Last updated
25 Jul 2025
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 Systemic Lupus Erythematosus (SLE) and Immune-mediated Necrotizing Myopathy (IMNM), run by RenJi Hospital at 1 site in China.

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 11 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Nan Shen, MD & PhD (+86-21-63260477, nanshensibs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events [Safety and Tolerability] (time frame: Throughout the first 24 months follow up period completion (3 years)，DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion). 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 NCT06249438.

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 25 Jul 2025.

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