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

Launched by RENJI HOSPITAL · Jan 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called C-CAR168 for adults with certain autoimmune diseases that haven’t responded well to standard therapies. These diseases include Systemic Lupus Erythematosus (SLE), Immune-Mediated Necrotizing Myopathy, Neuromyelitis Optica Spectrum Disorders, Multiple Sclerosis (in its relapsing form), and Myasthenia Gravis. The goal is to see if this new therapy can help patients whose conditions remain active despite receiving other treatments.

To participate in this trial, individuals must be between 18 and 70 years old and have been diagnosed with one of the listed autoimmune diseases for at least six months. They should have tried at least two different standard treatments without success. Participants will receive C-CAR168 therapy and will be monitored closely for its effects. This study is currently recruiting, and it’s important to note that certain health conditions, like active infections or a history of specific viral infections, may exclude someone from joining. Overall, the trial aims to explore a potentially promising new option for patients struggling with these challenging conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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) 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 at least two immunosuppressants (immunosuppressants or disease-modifying drug (DMD) for MS participants).
• • 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.
• • 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.
• • ≥ 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.
• • Pregnant or lactating women.
• • Severe central nervous system diseases or pathological changes.
• • Malignancy history within 5 years prior to signing the ICF.