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

Qingdao University

Status and phase

Not yet enrolling

Phase 1

Conditions

Myasthenia Gravis (MG)

Immune-Mediated Necrotizing Myopathy

Systemic Sclerosis

Neuromyelitis Optica Spectrum Disorder

Systemic Lupus Erythematosus

Multiple Sclerosis (MS)

Treatments

Biological: CD20/BCMA-directed CAR-T cells Autologous 2nd generation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07676266

1141-049

Details and patient eligibility

About

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

Enrollment

18 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 Multiple sclerosis (MS)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Myasthenia Gravis (MG)/Systemic Lupus Erythematosus (SLE)/ Systemic Sclerosis (SSc)/ Immune-Mediated Necrotizing Myopathy (IMNM) according to recognized diagnostic criteria for at least 6 months.
Prior treatment failure with standard therapy.
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, Epstein-Barr Virus (EBV) 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.
A history of ≥ Grade 2 bleeding within 4 weeks 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.
Any contraindication to lumbar puncture for MS or NMOSD.