Chimeric Antigen Receptors T Cells for Refractory/Recurrent Lupus Nephritis in Children

NCT06904729 | Recruiting Phase 3

• 1 other identifier: [2025]040A01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, open, single-arm clinical trial was to evaluate the safety and potential efficacy of CAR T cell therapy in children with refractory/recurrent lupus nephritis. The persistence and cell phenotype of CAR-T cells in vivo and CAR-T treatment-related inflammatory factors were evaluated after treatment. To explore new therapeutic methods, in order to reduce the side effects of traditional therapeutic drugs, increase curative effect, and finally make patients obtain long-term survival and improve survival quality.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Number of participants with CAR-T cells treatment-related adverse events(AE)

  Incidence and severity of treatment-related AE, including adverse event of special interest (AESI), as assessed by CTCAE v5.0.

  2 years

Secondary Outcomes (2)

• Overall renal response (ORR) rete

  2 years

• Number of participants with SRI-4 response

  2 years

Study Arms (1)

CAR-T

EXPERIMENTAL

Children who met the inclusion criteria were given transfusions of CAR-T cells

Biological: Low-dose CAR-T cells group; Biological: High-dose CAR-T cells group

Interventions

Low-dose CAR-T cells group BIOLOGICAL

This group of patients received low dose novel structure of Chimeric Antigen Receptors T (CAR-T) cells therapy with an infusion dose of approximately 5×100,000 cells/Kg.

CAR-T

High-dose CAR-T cells group BIOLOGICAL

This group of patients received high dose novel structure of Chimeric Antigen Receptors T (CAR-T) cells therapy with an infusion dose of approximately 1×1000,000 cells/Kg.

CAR-T

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 6-18 years old (including critical value);
• Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria;
• According to the 2018 ISN/RPS LN standards diagnosed with active Class III or IV LN, with or without a membranous component and the biopsy must be performed within 6 months prior to screening;
• SLEDAI-2000 score ≥8 points;
• Meeting the diagnosis of refractory lupus nephritis,
• defined as treatment with two or more immunosuppressants (including glucocorticoids, cyclophosphamide, tacrolimus, mycophenolic acid analogues, leflunomide, and cyclosporine) for more than 6 months without inducing remission or relapse after remission,
• accompanied by proteinuria without remission;
• Positive expression of CD19 in peripheral blood B cells determined by flow cytometry;
• Participants had good venous access, no contraindications for cell collection;
• Participants and their guardians sign the informed consent, understand the study procedures and participate in the clinical study voluntarily;
• The functions of important organs are basically normal:
• Hematopoietic function (blood routine should meet):
• Lymphocyte count ≥1×109/L,
• White blood cell count ≥3×109/L,
• Neutrophil count ≥1×109/L (no colony-stimulating factor treatment within 2 weeks prior to examination),

You may not qualify if:

• Received kidney transplant previously;
• Serious drug allergy history or allergy;
• Presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;
• Complicated with severe organ dysfunction of heart, liver, lung or coagulation dysfunction;
• Complicated with congenital immunoglobulin deficiency;
• Participants with infectious diseases:
• Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc Ab) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range;
• Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range;
• Human immunodeficiency virus (HIV) antibody positive;
• Syphilis positive;
• Diagnosed with malignant tumors in the last five years.
• Suffer from severe central nervous system disease, mental illness and severe cognitive dysfunction;
• Participated in other clinical trials within 3 months before enrollment;
• Received CAR-T therapy previously;

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (1)

Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, 510000, China

RECRUITING

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

Xia Gao, M.D.

CONTACT

86+020-81330569; gaoxiagz@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: April 1, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)