Multiple Sclerosis (MS)Phase 1NCT07676266
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 Autologous 2nd generation in people with Multiple Sclerosis (MS) and Myasthenia Gravis (MG), run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 autoimmune diseases refractory to standard therapy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis (MS), Myasthenia Gravis (MG), Neuromyelitis Optica Spectrum Disorder
- What is being tested?
- CD20/BCMA-directed CAR-T cells Autologous 2nd generation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Oct 2028
- 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)/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.
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 for MS or NMOSD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Qindao, Shandong, 266003
Min Liu, MD, 17853297267, liumin1968@yeah.net
Bin Liu, MD, 18661806287 ext. 053282919030, Binliu72314@163.com
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 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
- Conditions
- Multiple Sclerosis (MS), Myasthenia Gravis (MG), Neuromyelitis Optica Spectrum Disorder, Systemic Lupus Erythematosus, Systemic Sclerosis, Immune-Mediated Necrotizing Myopathy
- Being tested
- CD20/BCMA-directed CAR-T cells Autologous 2nd generation
- Keywords
- CD20/BCMA-directed CAR-T cells
- Medical subject headings
- Multiple Sclerosis, Myasthenia Gravis, Neuromyelitis Optica, Lupus Erythematosus, Systemic, 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 cells Autologous 2nd generationBiological
Also called C-CAR168
CD20/BCMA-directed CAR-T cells, single infusion intravenously
| Study group | Role | What they receive |
|---|---|---|
| C-CAR168 Autologous C-CAR168 administered by intravenous (IV) infusion | Experimental | Not described Receives: Biological: CD20/BCMA-directed CAR-T cells Autologous 2nd generation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The subsequent recommended dose of C-CAR168 in patients with 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 (20)
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
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
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
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
MS and NMOSD: Annualized Relapse Rate (ARR)
ARR at 6 months and 24 months post-infusion
Measured: Throughout the first 24 months follow up period completion
MG: Minimal Symptom Expression (MSE) and Minimal Clinically Important Difference (MCID)
Proportion of participants achieving MSE or MCID at 6 months and 24 months post-infusion
Measured: Throughout the first 24 months follow up period completion
MG: Quantitative Myasthenia Gravis Score (QMGS)
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.
Measured: Throughout the first 24 months follow up period completion
MG: Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale
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.
Measured: Throughout the first 24 months follow up period completion
SLE: Definition Of Remission In SLE (DORIS), Lupus Low Disease Activity State (LLDAS), Systemic Lupus Erythematosus Responder Index-4 (SRI-4)
Proportion of participants achieving DORIS or LLDAS or SRI-4 at 6 months post-infusion and during the study period
Measured: Throughout the first 24 months follow up period completion
SLE: Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),
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.
Measured: Throughout the first 24 months follow up period completion
IMNM: Definition Of Improvement (DOI)
Proportion of participants achieving DOI at 6 months post-infusion and during the study period
Measured: Throughout the first 24 months follow up period completion
IMNM: Manual Muscle Test (MMT)
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.
Measured: Throughout the first 24 months follow up period completion
SSc: Revised Composite Response Index in Systemic Sclerosis (r-CRISS)
Proportion of participants achieving r-CRISS at 6 months post-infusion and during the
Measured: Throughout the first 24 months follow up period completion
SSc: modified Rodnan Skin Score (mRSS), FVC%
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.
Measured: Throughout the first 24 months follow up period completion
PK：Maximal plasma concentration (Cmax)
Cmax of C-CAR168 in peripheral blood
Measured: Throughout the first 24 months follow up period completion
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
PK: Duration in peripheral blood (Tlast)
Tlast of C-CAR168 in peripheral blood
Measured: Throughout the first 24 months follow up period completion
PK: Area under curve (AUC)
AUC of C-CAR168 in peripheral blood
Measured: Throughout the first 24 months follow up period completion
PD: Depletion of peripheral blood B cells, plasma cells, and CD20dim T cells
Measured: Throughout the first 24 months follow up period completion
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.
- First posted30 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676266
- Sponsor's protocol ID
- 1141-049
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Autoimmune Diseases Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT07676266
- Acronym / sponsor ID
- 1141-049
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- Jul 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-CAR168 Autologous C-CAR168 administered by intravenous (IV) infusion | Experimental | Biological: CD20/BCMA-directed CAR-T cells Autologous 2nd generation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD20/BCMA-directed CAR-T cells Autologous 2nd generationAlso: C-CAR168CD20/BCMA-directed CAR-T cells, single infusion intravenously | Biological | C-CAR168 Autologous C-CAR168 administered by intravenous (IV) infusion |
Primary outcome
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
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
20 secondary outcomes
Incidence and severity of adverse events (AE)
Time frame: Throughout the first 24 months follow up period completion
MS: No Evidence of Disease Activity-3 (NEDA-3)
Time frame: Throughout the first 24 months follow up period completion
MS and NMOSD: Expanded Disability Status Scale (EDSS)
Time frame: Throughout the first 24 months follow up period completion
MS and NMOSD: MRI
Time frame: Throughout the first 24 months follow up period completion
MS and NMOSD: Annualized Relapse Rate (ARR)
Time frame: Throughout the first 24 months follow up period completion
MG: Minimal Symptom Expression (MSE) and Minimal Clinically Important Difference (MCID)
Time frame: Throughout the first 24 months follow up period completion
MG: Quantitative Myasthenia Gravis Score (QMGS)
Time frame: Throughout the first 24 months follow up period completion
MG: Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale
Time frame: Throughout the first 24 months follow up period completion
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
SLE: Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),
Time frame: Throughout the first 24 months follow up period completion
IMNM: Definition Of Improvement (DOI)
Time frame: Throughout the first 24 months follow up period completion
IMNM: Manual Muscle Test (MMT)
Time frame: Throughout the first 24 months follow up period completion
SSc: Revised Composite Response Index in Systemic Sclerosis (r-CRISS)
Time frame: Throughout the first 24 months follow up period completion
SSc: modified Rodnan Skin Score (mRSS), FVC%
Time frame: Throughout the first 24 months follow up period completion
PK：Maximal plasma concentration (Cmax)
Time frame: Throughout the first 24 months follow up period completion
PK: Time to reach the maximal plasma concentration (Tmax)
Time frame: Throughout the first 24 months follow up period completion
PK: Duration in peripheral blood (Tlast)
Time frame: Throughout the first 24 months follow up period completion
PK: Area under curve (AUC)
Time frame: Throughout the first 24 months follow up period completion
PD: Depletion of peripheral blood B cells, plasma cells, and CD20dim T cells
Time frame: Throughout the first 24 months follow up period completion
PD: Decline of serum immunoglobulin
Time frame: Throughout the first 24 months follow up period completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD20/BCMA-directed CAR-T cells Autologous 2nd generation in people with Multiple Sclerosis (MS) and Myasthenia Gravis (MG), run by The Affiliated Hospital of Qingdao University 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 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 30 Jun 2026. 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 Min Liu, MD (17853297267, liumin1968@yeah.net), 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?
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 30 Jun 2026.