NCT07676266Not yet recruitingPhase 1
A Study of C-CAR168 in the Treatment of 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 Autoimmune Diseases Refractory to Standard Therapy
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 24 Jun 2026
- Start date
- Jul 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Diseases
- Myasthenia gravis, Neuromyelitis optica (NMOSD), Lupus (SLE), Systemic sclerosis (scleroderma), Multiple sclerosis
- NCT number
- NCT07676266
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From Jul 2026 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Malignancy history within 5 years prior to signing the ICF.
Other illness
- 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.
- Severe central nervous system diseases or pathological changes.
Other
- Pregnant or lactating women.
- Any contraindication to lumbar puncture for MS or NMOSD.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.