Loading clinical trials...

Chimeric Antigen Receptors T Cells for Refractory/Recurrent Lupus Nephritis in Children | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

An Exploratory Clinical Study of the Safety and Efficacy of CAR-T in Children With Refractory/Recurrent Lupus Nephritis Disease

NCT06904729•Guangzhou Women and Children's Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 6-18 years old (including critical value);
•2. Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria;
•3. 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;
•4. SLEDAI-2000 score ≥8 points;
•5. Meeting the diagnosis of refractory lupus nephritis,
•1. 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,
•2. accompanied by proteinuria without remission;
•6. Positive expression of CD19 in peripheral blood B cells determined by flow cytometry;
•7. Participants had good venous access, no contraindications for cell collection;
•8. Participants and their guardians sign the informed consent, understand the study procedures and participate in the clinical study voluntarily;
+17 more criteria

Exclusion Criteria

•1. Received kidney transplant previously;
•2. Serious drug allergy history or allergy;
•3. Presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;
•4. Complicated with severe organ dysfunction of heart, liver, lung or coagulation dysfunction;
•5. Complicated with congenital immunoglobulin deficiency;
•6. Participants with infectious diseases:
•1. 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;
•2. Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range;
•3. Human immunodeficiency virus (HIV) antibody positive;
•4. Syphilis positive;
+5 more criteria

Locations (1)

Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, China

Key Dates

Start Date

May 1, 2025

Primary Completion Date

April 30, 2029

Completion Date

April 30, 2029

Last Updated

April 1, 2025

Enrollment

ESTIMATED participants

Conditions

Lupus Nephritis

Interventions

Low-dose CAR-T cells group

BIOLOGICAL

High-dose CAR-T cells group

BIOLOGICAL

Contacts

Xia Gao, M.D.

CONTACT

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

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT05126277

Lupus Nephritis

View study

RECRUITINGPHASE2

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Safety and Efficacy of ONT01 in Lupus

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

Lupus Landmark Study: A Prospective Registry and Biorepository