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New treatment option for Lupus Nephritis
Official title Chimeric Antigen Receptors T Cells for Refractory/Recurrent Lupus Nephritis in Children
ClinicalTrials.gov ID: NCT06904729
What this study is testing
What is Low-dose CAR-T cells group?
Low-dose CAR-T cells group is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus nephritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join 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...
- SLEDAI-2000 score ≥8 points;
- Meeting the diagnosis of refractory lupus nephritis,
You likely can't join 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:
See the full eligibility criteria
- 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...
- 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),
- Hemoglobin ≥60g/L;
- 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);
- Renal function: eGFR ≥30 ml/(min.1.73m2) (Schwartz formula, except abnormal renal function by SLE);
- Coagulation function:
- International standardized ratio (INR) ≤1.5×ULN,
- prothrombin time (PT) ≤1.5×ULN;
- Heart function: hemodynamic stability;
- Anti-nuclear antibody (ANA) ≥1:80;
- Eastern Cancer Cooperation Group (ECOG) physical status score 0 to 2.
- 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;
- Other situations that the researcher considers unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.