Universal CAR-T Cell Therapy for Refractory Lupus Nephritis

Early Phase 1

Not yet recruiting

• Conditions: Lupus Nephritis
• Interventions: Biological: BCMA CART + CD19 CART

• Registration Number: NCT06681337
• Lead Sponsor: Bioray Laboratories

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08
• Study Start: 2024-11-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BCMA CART + CD19 CART	BCMA CART + CD19 CART	BCMA CART + CD19 CART

Primary Outcome Measures

Name	Time	Method
AEs	Within 6 months after BCMA CART and CD19 CART infusion	The total number, incidence, and severity of AE

Secondary Outcome Measures

Name	Time	Method
ORR (CR and PR)	At 6 months after BCMA CART and CD19 CART infusion	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.