Universal CAR-T Cell Therapy for Refractory Lupus Nephritis
ConditionLupus Nephritis
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBioray Laboratories
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- BCMA CART + CD19 CART
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Bioray Laboratories
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Source ClinicalTrials.gov