A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy (CAR-AID)

Shanghai Jiao Tong University

Status and phase

Enrolling

Phase 1

Conditions

Myasthenia Gravis

Multiple Sclerosis-Relapsing-Remitting

Immune-Mediated Necrotizing Myopathy

Neuromyelitis Optica Spectrum Disorders

Systemic Lupus Erythematosus (SLE)

Treatments

Biological: CD20/BCMA-directed CAR-T cells

Study type

Interventional

Funder types

Other

Identifiers

NCT06249438

1141-043(CAR-AID)

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.