A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

Phase 1

Recruiting

• Conditions: Systemic Lupus Erythematosus (SLE); Immune-Mediated Necrotizing Myopathy; Neuromyelitis Optica Spectrum Disorders; Multiple Sclerosis-Relapsing-Remitting; Myasthenia Gravis

• Registration Number: NCT06249438
• Lead Sponsor: RenJi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-1-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> - 18 to 70 years old at the time of signing the Informed Consent Form (ICF).<br><br> - Diagnosed as SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica<br> Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG) according<br> to recognized diagnostic criteria for at least 6 months.<br><br> - Remains disease active or relapses after treatment with standard of care therapy for<br> at least 8 weeks with the dose stable for more than 2 weeks; patients should have<br> been treated at least two immunosuppressants (immunosuppressants or<br> disease-modifying drug (DMD) for MS participants).<br><br> - Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.<br><br>Exclusion Criteria:<br><br> - Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus<br> (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive.<br><br> - Uncontrolled active infection.<br><br> - Live vaccine injection within 4 weeks prior to signing the ICF.<br><br> - Major organ transplantation history or bone marrow/hematopoietic stem cell<br> transplantation history.<br><br> - Severe cardiovascular diseases within the past 6 months prior to screening.<br><br> - = Grade 2 bleeding within the past 30 days prior to screening, or requiring<br> long-term anticoagulants treatment.<br><br> - Inadequate washing time for previous treatment.<br><br> - Previously treated with CAR-T cell products or genetically modified T cell<br> therapies.<br><br> - Pregnant or lactating women.<br><br> - Severe central nervous system diseases or pathological changes.<br><br> - Malignancy history within 5 years prior to signing the ICF.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events [Safety and Tolerability];The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects who achieved remission at 6 months (6M);The proportion of subjects who achieved remission during the main study period;The proportion of subjects who experienced relapse during the main study period;Time to response (TTR);Progression-free survival (PFS);The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period;Maximal plasma concentration (Cmax);Time to reach the maximal plasma concentration (Tmax);Duration in peripheral blood (Tlast);Area under curve (AUC);The clearance of peripheral blood B cell;The decline of serum immunoglobulin;The elevation of peripheral blood complement;The decline of autoantibodies or other disease specific biomarkers