RecruitingPhase 3NCT06904729

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


Sponsor

Guangzhou Women and Children's Medical Center

Enrollment

50 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called High-dose CAR-T cells group and a biological treatment called Low-dose CAR-T cells group for people with lupus nephritis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLow-dose CAR-T cells group

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.

BIOLOGICALHigh-dose CAR-T cells group

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.


Locations(1)

Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, China

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NCT06904729


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