ClinicalTrials.gov record NCT06285279
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 1, single-group, open-label dose-escalation study will enroll a small number of people with relapsing or refractory autoimmune kidney diseases (examples include lupus nephritis, ANCA-associated vasculitis, PLA2R-related membranous nephropathy, and IgG4-related disease). Participants undergo leukapheresis to make autologous CAR-T cells, receive lymphodepletion chemotherapy, then a single intravenous infusion of FKC289 at one of several dose levels. The study follows participants for at least two years to monitor safety and disease measures. The study uses a BOIN dose-escalation design and plans to enroll about 6–12 participants.
What it is studying. Whether a single infusion of FKC289 (BCMA/CD19 dual-targeted CAR-T cells) is safe and how it affects kidney-disease measures in people with selected autoimmune kidney diseases.
What the researchers hope to learn. To evaluate safety (dose-limiting toxicities and adverse events) of FKC289 and to collect early data on renal responses, duration of response, progression-free survival, and overall survival in treated participants.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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).
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- FKC289
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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:
- 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
Exclusion criteria
- Participants who have received the following previous treatments:
- 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.
- 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).
- 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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will first have leukapheresis (blood cell collection) so their T cells can be manufactured into FKC289 CAR‑T cells. Bridging therapy may be allowed between cell collection and the conditioning period. Before infusion participants receive a 3‑day lymphodepletion regimen (fludarabine + cyclophosphamide), then after one day of rest receive a single intravenous CAR‑T infusion (given within about 30 minutes at the assigned dose). Participants are followed and monitored for safety and response, with at least 2 years of post‑infusion follow‑up and repeated assessments during that time.
How the study is structured. An interventional Phase 1, single-group, open-label dose-escalation trial. Participants give blood cells (leukapheresis) to make autologous CAR-T cells, may receive bridging therapy while cells are made, get lymphodepletion with fludarabine and cyclophosphamide for three days, then a single IV infusion of FKC289 at a preassigned dose. Four dose levels are planned and a BOIN (Bayesian Optimal Interval) method guides escalation. Participants are followed for safety and outcomes for at least two years after infusion.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on IgG4-related disease
Important dates
- Study start
- Mar 4, 2024
- Primary completion
- Dec 31, 2026 (estimated)
- Study completion
- Dec 31, 2028 (estimated)
- Target enrollment
- 24 participants (estimated)
- Last updated on registry
- Jul 6, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Nanjing University School of Medicine
- Principal investigator
- Zhi-Hong Liu, MD, Professor
Nanjing University School of Medicine
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Xianghua Huang, MD 📞 13770648824 ✉ hxhszb@163.com
Participating sites (1)
- Jinling HospitalRecruiting
Nanjing, Jiangsu, 210016 · China
- Xianghua Huang, MD · 13770648824 · hxhszb@163.com
Terms used on this page · explanations by MedicalUpdates.ai
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- dose-escalation
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- relapsed or refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- inclusion criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- eGFR
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- Relapse
- A condition that improved with treatment and has since returned or worsened.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- ECOG performance status
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Absolute neutrophil count
- The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
- investigational drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- prior to screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- prednisone
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- chimeric antigen receptor
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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