Universal CAR-T Cell Therapy for Refractory Lupus Nephritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BCMA CART + CD19 CART.
- Who it may be relevant to
- Registry conditions: Lupus Nephritis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 for the Treatment of Refractory Lupus Nephritis
Overview
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.
Detailed 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.
Interventions
- Biological BCMA CART + CD19 CART
BCMA CART + CD19 CART
Primary outcome measures
- AEs [Time frame: Within 6 months after BCMA CART and CD19 CART infusion]
Secondary outcome measures (1)
- ORR (CR and PR) [Time frame: At 6 months after BCMA CART and CD19 CART infusion]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06681337 · 2024-BRL-302-03