A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 for the Treatment of Refractory Lupus Nephritis

Bioray Laboratories0 sites10 target enrollmentNovember 25, 2024

ConditionsLupus Nephritis

InterventionsBCMA CART + CD19 CART

DrugsBCMA CART + CD19 CART

Overview

Phase: Early Phase 1
Intervention: BCMA CART + CD19 CART
Conditions: Lupus Nephritis
Sponsor: Bioray Laboratories
Enrollment: 10
Primary Endpoint: AEs
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 25, 2024

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bioray Laboratories

Responsible Party

Sponsor

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 ≥
•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.

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.