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

Chimeric Antigen Receptors T Cells for Refractory/Recurrent Lupus Nephritis in Children (NCT06904729) is a Phase 3 interventional studying Lupus Nephritis, sponsored by Guangzhou Women and Children's Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Lupus Nephritis, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 50 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Lupus Nephritis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form, understand the study procedures and participate in the clinical study voluntarily; 9. The functions of important organs are basically normal: 1. 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), - blood count (hemoglobin) at least 60g/L; 2. Liver function: - ALT≤3×ULN (except elevated ALT caused by inflammatory myopathy), - AST≤3×ULN (except for elevated AST caused by inflammatory myopathy), - TBIL≤1.5×ULN (except Gilbert syndrome, total bilirubin ≤3.0×ULN); 3. Renal function: eGFR ≥30 ml/(min.1.73m2) (Schwartz formula, except abnormal renal function by SLE); 4. Coagulation function: - International standardized ratio (INR) ≤1.5×ULN, - prothrombin time (PT) ≤1.5×ULN; 5. Heart function: hemodynamic stability; 10. Anti-nuclear antibody (ANA) ≥1:80; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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; 9. The functions of important organs are basically normal: 1. 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), * Hemoglobin ≥60g/L; 2. Liver function: * ALT≤3×ULN (except elevated ALT caused by inflammatory myopathy), * AST≤3×ULN (except for elevated AST caused by inflammatory myopathy), * TBIL≤1.5×ULN (except Gilbert syndrome, total bilirubin ≤3.0×ULN); 3. Renal function: eGFR ≥30 ml/(min.1.73m2) (Schwartz formula, except abnormal renal function by SLE); 4. Coagulation function: * International standardized ratio (INR) ≤1.5×ULN, * prothrombin time (PT) ≤1.5×ULN; 5. Heart function: hemodynamic stability; 10. Anti-nuclear antibody (ANA) ≥1:80; 11. Eastern Cancer Cooperation Group (ECOG) physical status score 0 to 2. 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; 7. Diagnosed with malignant tumors in the last five years. 8. Suffer from severe central nervous system disease, mental illness and severe cognitive dysfunction; 9. Participated in other clinical trials within 3 months before enrollment; 10. Received CAR-T therapy previously; 11. Other situations that the researcher considers unsuitable for inclusion.

Treatments Being Tested

BIOLOGICAL

Low-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.

BIOLOGICAL

High-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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06904729), the sponsor (Guangzhou Women and Children's Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06904729 clinical trial studying?

Who can participate in NCT06904729?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06904729?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06904729. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06904729. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.