Lupus NephritisPhase 1NCT06285279
The BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases
A Phase 1 study testing FKC289 in people with Lupus Nephritis and ANCA-associated Vasculitis, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10^6 cells/kg, 1.0×10^6 cells/kg, 3.0×10^6 cells/kg, and an alternative… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis, ANCA-associated Vasculitis, Membranous Nephropathy - PLA2R Induced
- What is being tested?
- FKC289
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2024to 31 Dec 2028
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study.
- Participants must be aged ≥18 and ≤65 years.
- Disease-specific inclusion criteria:
- Active, relapsing, refractory Lupus Nephritis (LN):
- LN diagnosed by kidney biopsy within the last 2 years, with pathological types III, IV, or V, and a chronicity index (CI) score≤3
- Meets one of the following criteria:
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- Refractory LN, defined as no remission after at least one standard regimen (CTX and/or MMF) for 6 months.
- Relapsing LN, defined as a need to increase steroid dosage to control disease activity during maintenance treatment.
- Clinical criteria: eGFR > 45 ml/min/1.73 m²; urinary protein quantification ≥ 1.5g/24h; SLE-DAI score ≥ 8.
- ANCA-associated vasculitis (AAV) patients:
- Diagnosed as AAV according to the 2012 Chapel Hill Consensus Conference criteria, meeting one of the following:
- Newly diagnosed AAV with renal involvement:
- Renal involvement must meet both:
- Kidney biopsy showing pauci-immune necrotizing glomerulonephritis. Urinary red blood cells >30/high power field.
- Relapsing or refractory AAV:
- Relapse: Defined as an increase in BVAS V3.0 score of ≥1 after remission, requiring adjustment of immunosuppressive treatment to regain remission.
- Refractory: Defined as a) less than 50% reduction in BVAS V3.0 after 6 weeks of standard induction treatment; or b) persistent disease activity (BVAS V3.0 ≥3) after 12 weeks of treatment.
- Membranous nephropathy (MN) patients:
- Tissue biopsy diagnosed as aPLA2R-related membranous nephropathy.
- Clinical criteria for high-risk or relapsing/refractory membranous nephropathy:
- High-risk patients:
- Defined as meeting any of the following: eGFR normal, urinary protein >3.5g/d, ACEI/ARB treatment for 6 months with <50% reduction in urinary protein, combined with serum albumin <25g/l or aPLA2R >50RU/ml; or eGFR <60ml/min/1.73m², and/or urinary protein >8g/d for over 6 months.
- Refractory/relapsing membranous nephropathy patients:
- Refractory: Defined as resistance to previous immunosuppressive treatment (persistent urinary protein ≥3.5g/d with <50% reduction compared to baseline).
- Relapse: Defined as complete or partial remission achieved with previous immunosuppressive treatment, followed by reappearance of urinary protein ≥3.5g/d.
- eGFR ≥ 45 ml/min/1.73 m².
- IgG4-related disease patients:
- Meeting the 2019 ACR/EULAR diagnostic criteria for IgG4-related disease, and meeting one of the following:
- Newly diagnosed active IgG4-related disease (Respond Index (RI) ≥3).
- Refractory or relapsed IgG4-related disease:
- Refractory: Defined as no remission with steroid or steroid plus immunosuppressant treatment (no clinical or imaging improvement, RI decrease <2) Relapse: Defined as new progression or recurrence of clinical symptoms or imaging findings in a patient who had achieved remission, with or without elevated blood IgG4 (RI increase≥2)
- Expected survival ≥ 12 weeks.
- ECOG performance status ≤ 2.
- Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of <1% per year.
- Participants must have adequate organ function, meeting all of the following criteria before enrollment:
- Absolute neutrophil count ≥ 1.0×10⁹/L [Granulocyte colony-stimulating factor (G-CSF) support is allowed, but no supportive treatment should be received within 7 days before the assessment].
- Platelet count ≥ 50×10⁹/L [No transfusion support (including component transfusion) or treatments aimed
Who cannot join
- Participants who have received the following previous treatments:
- 1.1 Participants who have received gene therapy before enrollment. 1.2 Participants who have been injected with live vaccines within 4 weeks prior to enrollment.
- 1.3 Participants who have received other investigational drug treatments within 12 weeks before apheresis.
- Participants with active malignancies within the past 5 years, except for tumors deemed curable and cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.
- Participants who are positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA tests (defined as HBV DNA quantification above the lower limit of detection or above the normal reference range of the testing center, or qualitative HBV DNA test positive); positive for Hepatitis C virus (HCV) antibodies with positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis test RPR.
- Participants with uncontrolled active infections (except for < Grade 2 CTCAE urinary reproductive system infections and upper respiratory infections).
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- Participants with severe heart diseases, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] class ≥ III), severe arrhythmias.
- Participants with hypertension or diabetes that cannot be controlled with medication.
- Participants with unresolved toxic reactions from previous treatments to baseline or ≤ Grade 1 (according to NCI-CTCAE v5.0, except for alopecia and clinically insignificant lab abnormalities).
- Participants who have undergone major surgery within 2 weeks prior to enrollment or plan to have surgery during the waiting period for infusion or within 12 weeks after receiving study treatment (except for planned minor surgeries under local anesthesia).
- Participants with solid organ transplants.
- Pregnant or breastfeeding women.
- Participants with a history of central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, dementia, psychosis, etc.) or consciousness disorders.
- Participants with other unstable systemic diseases as judged by the researcher, including but not limited to severe diseases of the liver, kidneys, gastrointestinal tract, or metabolic diseases requiring medication.
- Participants are known to have life-threatening allergic reactions, hypersensitivity, or intolerance to FKC289 cellular products or their components.
- Participants judged by the researcher to have bleeding, severe thrombosis, or hereditary/acquired bleeding and severe thrombosis conditions (including hemophilia, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.), or patients currently undergoing thrombolytic or anticoagulant therapy.
- Participants who have received any B cell-depleting therapy or non-depleting B cell targeted therapy within 6 months.
- Participants who have received high-dose methylprednisolone treatment (cumulative dose > 1.5g) or cyclophosphamide pulse therapy within a month.
- Participants judged by the researcher to be unable to discontinue other immunosuppressants one week before apheresis, or those treated with more than 5 mg/day of prednisone (or equivalent dose of other corticosteroids).
- AAV patients diagnosed with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome) or with active alveolar hemorrhage.
- Other conditions deemed by the researcher as unsuitable for enrollment.
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
Jinling Hospital
Nanjing, Jiangsu, 210016
Xianghua Huang, MD, 13770648824, hxhszb@163.com
About this study
Official title: Evaluation of the Safety and Efficacy of the BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases: A Single-center Exploratory Clinical Study
This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10^6 cells/kg, 1.0×10^6 cells/kg, 3.0×10^6 cells/kg, and an alternative dose of 0.1×10^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).
Read the detailed description
A leukapheresis procedure will be performed to manufacture FKC289 chimeric antigen receptor (CAR) modified T cells. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of the BCMA/CD19 dual targeted CAR-T cells at 0.1, 0.3, 1.0, or 3.0x 10^6 CAR+ T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after FKC289 infusion.
- Conditions
- Lupus Nephritis, ANCA-associated Vasculitis, Membranous Nephropathy - PLA2R Induced, IgG4-Related Diseases
- Being tested
- FKC289
- Medical subject headings
- Lupus Nephritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FKC289Drug
The autologous dual target BCMA/CD19-CAR-T cell of this study is obtained by infecting T cells with anti-BCMA/CD19-CAR lentiviral vectors.
Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Administration of the BCMA/CD19 dual targeted CAR-T cells Four dose groups of 0.1×10^6 CAR-T/kg, 0.3×10^6 CAR-T/kg, 1.0×10^6 CAR-T/kg, and 3.0×10^6 CAR-T/kg FKC289 are designed in this study.
Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, IgG4-related diseases) according to observed DLT.
the BCMA/CD19 dual targeted CAR-T cells will be intravenously infused at least 24 hours after lymphodepletion preconditioning. According to the assigned dose group, the designated dose of the BCMA/CD19 dual targeted CAR-T cells will be infused in a single infusion within 30 minutes on day 0. Receives: Drug: FKC289 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with dose-limiting toxicity
The number of participants with dose limiting toxicity in each dose group and the type of dose limiting toxicity that occurred.
Measured: Within 28 days after the BCMA/CD19 dual targeted CAR-T cells injection infusion
The proportion of subjects with adverse events
All adverse events were evaluated according to NCI-CTCAE v5.0 criteria.
Measured: Within 24 weeks after the BCMA/CD19 dual targeted CAR-T cells injection infusion
Secondary outcomes (4)
Proportion of subjects achieving renal response
The proportion of participants who achieve partial remission (PR) or complete remission (CR) of renal.
Measured: Within 6 months after the BCMA/CD19 dual targeted CAR-T cells injection infusion
Duration of response (DoR) of all subjects
The time from FKC289 infusion to the first assessment of CR/PR until the first assessment of disease progression/relapse or death due to the study disease
Measured: Within 2 years after the BCMA/CD19 dual targeted CAR-T cells injection infusion
Progression-free survival (PFS) of all subjects
Time from the first FKC289 infusion to the first assessment of disease progression/relapse or death from any cause.
Measured: Within 2 years after the BCMA/CD19 dual targeted CAR-T cells injection infusion
Overall survival (OS) of all subjects
Time from the first FKC289 infusion to death from any cause.
Measured: Within 2 years after the BCMA/CD19 dual targeted CAR-T cells injection infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start4 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-Hong Liu, MD, Nanjing University School of Medicine
- Investigators
- Zhihong Liu, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285279
- Sponsor's protocol ID
- NJCT-2401
- Status last verified
- Jul 2026
- First submitted
- 22 Feb 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases: A Single-center Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06285279
- Acronym / sponsor ID
- NJCT-2401
- Conditions
- Lupus Nephritis, ANCA-associated Vasculitis, Membranous Nephropathy - PLA2R Induced, IgG4-Related Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Feb 2024 (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.
This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10^6 cells/kg, 1.0×10^6 cells/kg, 3.0×10^6 cells/kg, and an alternative dose of 0.1×10^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).
Detailed description
A leukapheresis procedure will be performed to manufacture FKC289 chimeric antigen receptor (CAR) modified T cells. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of the BCMA/CD19 dual targeted CAR-T cells at 0.1, 0.3, 1.0, or 3.0x 10^6 CAR+ T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after FKC289 infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: FKC289Administration of the BCMA/CD19 dual targeted CAR-T cells Four dose groups of 0.1×10^6 CAR-T/kg, 0.3×10^6 CAR-T/kg, 1.0×10^6 CAR-T/kg, and 3.0×10^6 CAR-T/kg FKC289 are designed in this study. Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, IgG4-related diseases) according to observed DLT. the BCMA/CD19 dual targeted CAR-T cells will be intravenously infused at least 24 hours after lymphodepletion preconditioning. According to the assigned dose group, the designated dose of the BCMA/CD19 dual targeted CAR-T cells will be infused in a single infusion within 30 minutes on day 0. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study.
- Participants must be aged ≥18 and ≤65 years.
- Disease-specific inclusion criteria:
- LN diagnosed by kidney biopsy within the last 2 years, with pathological types III, IV, or V, and a chronicity index (CI) score≤3
- Refractory LN, defined as no remission after at least one standard regimen (CTX and/or MMF) for 6 months.
Key exclusion criteria (21 listed)
- Participants who have received the following previous treatments:
- 1.1 Participants who have received gene therapy before enrollment. 1.2 Participants who have been injected with live vaccines within 4 weeks prior to enrollment.
- 1.3 Participants who have received other investigational drug treatments within 12 weeks before apheresis.
- Participants with active malignancies within the past 5 years, except for tumors deemed curable and cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.
- Participants who are positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA tests (defined as HBV DNA quantification above the lower limit of detection or above the normal reference range of the testing center, or qualitative HBV DNA test positive); positive for Hepatitis C virus (HCV) antibodies with positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis test RPR.
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 |
|---|---|---|
| FKC289The autologous dual target BCMA/CD19-CAR-T cell of this study is obtained by infecting T cells with anti-BCMA/CD19-CAR lentiviral vectors. Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. | Drug | Treatment arm |
Primary outcome
The proportion of subjects with dose-limiting toxicity
Time frame: Within 28 days after the BCMA/CD19 dual targeted CAR-T cells injection infusion
The number of participants with dose limiting toxicity in each dose group and the type of dose limiting toxicity that occurred.
The proportion of subjects with adverse events
Time frame: Within 24 weeks after the BCMA/CD19 dual targeted CAR-T cells injection infusion
All adverse events were evaluated according to NCI-CTCAE v5.0 criteria.
4 secondary outcomes
Proportion of subjects achieving renal response
Time frame: Within 6 months after the BCMA/CD19 dual targeted CAR-T cells injection infusion
Duration of response (DoR) of all subjects
Time frame: Within 2 years after the BCMA/CD19 dual targeted CAR-T cells injection infusion
Progression-free survival (PFS) of all subjects
Time frame: Within 2 years after the BCMA/CD19 dual targeted CAR-T cells injection infusion
Overall survival (OS) of all subjects
Time frame: Within 2 years after the BCMA/CD19 dual targeted CAR-T cells injection infusion
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 6 Jul 2026.
- 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.
Zhihong Liu principal investigator
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FKC289 in people with Lupus Nephritis and ANCA-associated Vasculitis, run by Nanjing University School of Medicine 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 37 inclusion and 21 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 6 Jul 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xianghua Huang, MD (13770648824, hxhszb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with dose-limiting toxicity (time frame: Within 28 days after the BCMA/CD19 dual targeted CAR-T cells injection infusion). The study lists 2 primary outcomes in all. 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 6 Jul 2026.