A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
- Sponsor
- The Affiliated Hospital of Qingdao University
- Study ID
- NCT07676266
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Immune-Mediated Necrotizing Myopathy
- Multiple Sclerosis (MS)
- Myasthenia Gravis (MG)
- Neuromyelitis Optica Spectrum Disorder
- Systemic Lupus Erythematosus
- Systemic Sclerosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- CD20/BCMA-directed CAR-T cells Autologous 2nd generation — BIOLOGICALCD20/BCMA-directed CAR-T cells, single infusion intravenously
Study Details
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
Key Dates
- Start date
- Jul 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Nov 30, 2027
- Completion
- Oct 31, 2028
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: C-CAR168 Autologous C-CAR168 administered by intravenous (IV) infusion
Primary Outcome Measure
Incidence and severity of Adverse Events [Safety and Tolerability] [ Time Frame: Throughout the first 3 months follow up period completion ]
Central Contacts
- Min Liu, MD17853297267
- Bin Liu, MD18661806287
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