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New treatment option for Lupus Nephritis
Official title The BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases
ClinicalTrials.gov ID: NCT06285279
What this study is testing
What is FKC289?
FKC289 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
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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 Active, relapsing, refractory Lupus Nephritis (LN): LN diagnosed by kidney biopsy within the last 2 years, with pathological types...
- Expected survival ≥ 12 weeks.
- ECOG performance status ≤ 2.
You likely can't join if
- Participants who have received the following previous treatments: 1.1 Participants who have received gene therapy before enrollment. 1.2 Participants...
- Participants with active malignancies within the past 5 years, except for tumors deemed curable and cured, such as basal or squamous cell carcinoma...
- Participants who are positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA...
- Participants with uncontrolled active infections (except for \< Grade 2 CTCAE urinary reproductive system infections and upper respiratory...
- Participants with severe heart diseases, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening)...
- Participants with hypertension or diabetes that cannot be controlled with medication.
See the full eligibility criteria
Who can 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 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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 ≥...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, 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.