Universal CAR-T Cell Therapy for Refractory Lupus Nephritis

NCT06681337 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2024-BRL-302-03
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• AEs

  The total number, incidence, and severity of AE

  Within 6 months after BCMA CART and CD19 CART infusion

Secondary Outcomes (1)

• ORR (CR and PR)

  At 6 months after BCMA CART and CD19 CART infusion

Other Outcomes (1)

• PK/PD

  Within 3 months after BCMA CART and CD19 CART infusion

Study Arms (1)

BCMA CART + CD19 CART

EXPERIMENTAL

BCMA CART + CD19 CART

Biological: BCMA CART + CD19 CART

Interventions

BCMA CART + CD19 CART BIOLOGICAL

BCMA CART + CD19 CART

BCMA CART + CD19 CART

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioray Laboratories: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Dandan Wang, PhD

CONTACT

15850515316; dangdangwang2007@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 8, 2024
• Study Start: November 25, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-09