NCT06249438RecruitingPhase 1
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
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
Source: ClinicalTrials.gov · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Jan 2024
- Start date
- 20 Mar 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Myasthenia gravis, Neuromyelitis optica (NMOSD), Lupus (SLE), Systemic sclerosis (scleroderma), Multiple sclerosis
- NCT number
- NCT06249438
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 20 Mar 2024 to the primary completion date, Mar 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.
- ≥ Grade 2 bleeding within the past 30 days 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.
Who the study is looking for
- 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.
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 |
|---|---|---|---|
| Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.