Universal CAR-T Cell Therapy for Refractory Lupus Nephritis

Bioray Laboratories

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Lupus Nephritis

Treatments

Biological: BCMA CART + CD19 CART

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06681337

2024-BRL-302-03

Details and patient eligibility

About

This investigator-initiated trial aims to assess the efficacy and safety of combination therapy using universal CAR-T cells targeting BCMA and CD19 in refractory lupus nephritis.

Full description

This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for refractory lupus nephritis using universal CAR-T cells targeting BCMA and CD19.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 18-65 years; both genders eligible.
Subjects diagnosed with lupus nephritis.
Previous treatment outcomes were unsatisfactory.
Diagnosis of active nephritis type III or IV with or without type V according to 2018 International Society of Nephrology and Society of Renal Pathology (ISN/RPS) criteria.
NIH Activity Index > 2 and elevated chronicity index.
Urine protein: creatinine ratio (UPCR) ≥ 1.0 g/g, or 24-hour urine protein ≥ 1.0 g, with or without active urine sediment with red blood cell casts.
Receiving hormones with or without antimalarials.
SLEDAI-2K score ≥ 6.
Antinuclear antibody positive, and/or anti-ds-DNA antibody positive, and/or anti-Smith antibody positive.
Positive expression of CD19 on B cells in peripheral blood.
Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
Provides written informed consent.

Exclusion criteria

History of solid organ transplantation.
Malignant tumor within the last two years.
Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
Primary immunodeficiency (congenital or acquired).
Severe cardiac disease.
History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
Allergic constitution or a history of severe allergies.
Pregnant or breastfeeding women.