ClinicalTrials.gov record NCT07341828
A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is an investigator-initiated, single-center, open-label Phase 1 study of C-CAR168, an autologous CD20/BCMA-directed CAR-T cell product, for adults (18–70) with central nervous system autoimmune diseases that have not responded to standard therapy. Participants receive a single intravenous infusion of C-CAR168 and are followed for safety, dose recommendation, and clinical and laboratory measures up to 24 months. The earliest safety assessments focus on adverse events in the first 3 months after infusion.
What it is studying. The study is testing C-CAR168, an autologous bi-specific CAR-T therapy that targets CD20 and BCMA, to evaluate its safety, tolerability, and recommended dose in adults with CNS autoimmune diseases refractory to standard treatments. It also measures clinical outcomes and how the product behaves in the blood over time.
What the researchers hope to learn. Scientific goals are to assess safety and tolerability of C-CAR168; determine a recommended dose based on safety data; describe clinical outcomes relevant to each condition (for example NEDA‑3 and EDSS in MS; MRI lesion measures; disease-specific scales for autoimmune encephalitis and stiff-person syndrome); and measure pharmacokinetics and pharmacodynamics such as CAR‑T levels in blood, B‑cell and plasma cell depletion, and changes in serum immunoglobulins.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- CD20/BCMA-directed CAR-T cells
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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)/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.
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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive a single intravenous (IV) infusion of autologous C-CAR168 (CD20/BCMA-directed CAR‑T cells). You would have safety monitoring with more intensive follow-up during the first 3 months and additional visits over a total follow-up of up to 24 months. Study procedures named in the record include blood draws to measure CAR‑T levels and immune effects, brain MRI scans to assess lesions and brain volume, and neurological assessments using scales such as EDSS, CASE, DSI, and HSS at 6 and 24 months. The study may require a lumbar puncture (spinal tap); people with any contraindication to lumbar puncture are excluded. The study will collect and record adverse events and serious adverse events throughout the follow-up periods.
How the study is structured. Interventional Phase 1, open-label (no masking) with a single experimental arm. Participants undergo manufacturing of their own (autologous) CAR‑T cells and receive one intravenous infusion of C-CAR168. The study uses a sequential intervention model and includes planned follow-up visits and assessments for safety, clinical scales, MRI changes, relapse rate, and pharmacokinetics/pharmacodynamics over a 24-month period; safety in the first 3 months is a primary focus.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on stiff person syndrome
This trial is also listed on this site under autoimmune encephalitis.
Important dates
- Study start
- February 2026 (estimated)
- Primary completion
- June 2027 (estimated)
- Study completion
- February 2029 (estimated)
- Target enrollment
- 15 participants (estimated)
- Last updated on registry
- Jan 15, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Huashan Hospital
- Principal investigator
- Xiangjun Chen, Professor of Neurology
Huashan Hospital - Collaborators
- Shanghai AbelZeta Ltd.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Xiangjun Chen 📞 +86 21 52888159 ✉ xiangjchen@fudan.edu.cn
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- CAR-T
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- standard therapy
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- Informed Consent Form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Prior treatment
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- prior to screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- lumbar puncture
- A procedure in which a needle is placed between the bones of the lower back to collect spinal fluid or to give a treatment.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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