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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

The BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases

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

The BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases (NCT06285279) is a Phase 1 interventional studying Lupus Nephritis and ANCA-associated Vasculitis, sponsored by Nanjing University School of Medicine. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Lupus Nephritis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

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.

With a target enrollment of 24 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants must personally sign an willing to sign a consent form form approved by the Ethics Committee before the start of the study. 2. Participants must be aged ≥18 and ≤65 years. 3. Disease-specific Who May Qualify: 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: 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: ...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. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study. 2. Participants must be aged ≥18 and ≤65 years. 3. 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: 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) 4. Expected survival ≥ 12 weeks. 5. ECOG performance status ≤ 2. 6. 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. 7. Participants must have adequate organ function, meeting all of the following criteria before enrollment: 1. Absolute neutrophil count ≥ 1.0×10⁹/L \[Granulocyte colony-stimulating factor (G-CSF) support is allowed, but no supportive treatment should be received within 7 days before the assessment\]. 2. Platelet count ≥ 50×10⁹/L \[No transfusion support (including component transfusion) or treatments aimed Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Participants with uncontrolled active infections (except for \< Grade 2 CTCAE urinary reproductive system infections and upper respiratory infections). 5. 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. 6. Participants with hypertension or diabetes that cannot be controlled with medication. 7. 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). 8. 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). 9. Participants with solid organ transplants. 10. Pregnant or breastfeeding women. 11. Participants with a history of central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, dementia, psychosis, etc.) or consciousness disorders. 12. 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. 13. Participants are known to have life-threatening allergic reactions, hypersensitivity, or intolerance to FKC288 cellular products or their components. 14. 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. 15. Participants who have received any B cell-depleting therapy or non-depleting B cell targeted therapy within 6 months. 16. Participants who have received high-dose methylprednisolone treatment (cumulative dose \> 1.5g) or cyclophosphamide pulse therapy within a month. 17. 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). 18. AAV patients diagnosed with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome) or with active alveolar hemorrhage. 19. Other conditions deemed by the researcher as unsuitable for enrollment.

Treatments Being Tested

DRUG

FKC288

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.

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.

Jinling Hospital
Nanjing, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06285279), the sponsor (Nanjing University School of Medicine), 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 NCT06285279 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06285279?

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 NCT06285279?

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 NCT06285279. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06285279. 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.