Lupus NephritisPhase 3CAR-TNCT06904729
Chimeric Antigen Receptors T Cells for Refractory/Recurrent Lupus Nephritis in Children
A Phase 3 study testing Low-dose CAR-T cells group and High-dose CAR-T cells group in people with Lupus Nephritis, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Low-dose CAR-T cells group and High-dose CAR-T cells group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 30 Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, 510000
Xia Gao, M.D., 86+020-81330569, gaoxiagz@vip.163.com
Xia Gao
About this study
Official title: An Exploratory Clinical Study of the Safety and Efficacy of CAR-T in Children With Refractory/Recurrent Lupus Nephritis Disease
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
- Being tested
- Low-dose CAR-T cells group, High-dose CAR-T cells group
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose CAR-T cells groupBiological
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.
High-dose CAR-T cells groupBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T | Experimental | Children who met the inclusion criteria were given transfusions of CAR-T cells Receives: Biological: Low-dose CAR-T cells group; Biological: High-dose CAR-T cells group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Overall renal response (ORR) rete
ORR rate: Number of participants meet the complete renal response (CRR) or partial renal response (PRR) as a percentage of total participants. Follow-up for 2 years after CAR-T cells reinfusion, monitored and recorded ORR at study set time points (Month 3, Month 6, Month 12, Month 24, or participant withdrawal from the study).
Measured: 2 years
Number of participants with SRI-4 response
Number of participants with SLE response Index 4(SRI-4) response: including Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) 2000 scores decreased by ≥4 points from baseline, PGA with no worsening (VAS increased by <0.30 points from baseline), British Isles Lupus Assessment Group(BILAG) 2004 with no new A domain score and no more than 1 new B domain scores. Follow-up for 2 years after CAR-T cells reinfusion, monitored and recorded SRI-4 response at study set time points (Month 3, Month 6, Month 12, Month 24, or participant withdrawal from the study).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904729
- Sponsor's protocol ID
- [2025]040A01
- Acronym
- CAR-T
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of the Safety and Efficacy of CAR-T in Children With Refractory/Recurrent Lupus Nephritis Disease
- ClinicalTrials.gov ID
- NCT06904729
- Acronym / sponsor ID
- CAR-T / [2025]040A01
- Conditions
- Lupus Nephritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T | Experimental | Biological: Low-dose CAR-T cells group, Biological: High-dose CAR-T cells groupChildren who met the inclusion criteria were given transfusions of CAR-T cells |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (27 listed)
- 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,
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose CAR-T cells groupThis 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 | CAR-T |
| High-dose CAR-T cells groupThis 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. | Biological | CAR-T |
Primary outcome
Number of participants with CAR-T cells treatment-related adverse events(AE)
Time frame: 2 years
Incidence and severity of treatment-related AE, including adverse event of special interest (AESI), as assessed by CTCAE v5.0.
2 secondary outcomes
Overall renal response (ORR) rete
Time frame: 2 years
Number of participants with SRI-4 response
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-dose CAR-T cells group and High-dose CAR-T cells group in people with Lupus Nephritis, run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Gao, M.D. (86+020-81330569, gaoxiagz@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with CAR-T cells treatment-related adverse events(AE) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.