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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
BCMA CART + CD19 CART
Biological/VaccineBCMA CART + CD19 CART
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: BCMA CART + CD19 CARTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
AEs
The total number, incidence, and severity of AE
Time frame
Within 6 months after BCMA CART and CD19 CART infusionSecondary outcomes
1
ORR (CR and PR)
Complete response (CR) was defined as serum creatinine ≤ 1.2 mg/dl or ≤ 125% of baseline value, and urine protein/creatinine ratio \< 0.5 or 24-hour urine protein quantification \< 0.5 g, and prednisone dose reduction to ≤ 10 mg/d (or equivalent dose). Partial response (PR) was defined as if both serum creatinine and urine protein/creatinine ratio (or 24-hour urine protein quantification) were abnormal before treatment, both items improved by \> 30% after treatment, without other indicators of deterioration; if only urine protein/creatinine ratio (or 24-hour urine protein quantification) was abnormal before treatment, the improvement was \> 50% after treatment.
Time frame
At 6 months after BCMA CART and CD19 CART infusionOther outcomes
1
PK/PD
Changes and duration of CAR gene copy number and CAR-T cell number in peripheral blood after BCMA CART and CD19 CART infusion
Time frame
Within 3 months after BCMA CART and CD19 CART infusionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bioray Laboratories
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Source ClinicalTrials.gov
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