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New treatment option for Lupus Nephritis
Official title Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells
ClinicalTrials.gov ID: NCT06277427
What this study is testing
What is PRG-1801 （CAR-T against BCMA）?
PRG-1801 （CAR-T against BCMA） is an investigational medicine, 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
- Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells.
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 70
You may be able to join if
- Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
- If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL/minute/1.73 m2;
- The following test values within 3 days before the collection of mononuclear cells meet the following standards:
- Absolute lymphocyte count: ≥ 0.5 × 10 \^ 9/L [The use of granulocyte colony-stimulating factor (G CSF) is allowed, but people are not allowed to...
- Absolute neutrophil count: ≥ 1.0 × 10 \^ 9/L [The use of granulocyte colony-stimulating factor (G-CSF) is allowed, but people are not allowed to...
You likely can't join if
- -people who meet any of the following criteria should be excluded from this study:
- Pregnant or lactating women;
- If combined with alveolar hemorrhage, invasive pulmonary ventilation is required;
- Refractory GPA and MPA: Combined with other autoimmune diseases involving multiple organ systems, such as EGPA, SLE, IgA vasculitis (Henoch...
- Difficult to treat LN: severe extrarenal clinical manifestations such as lupus encephalopathy, pulmonary hemorrhage, lupus myocarditis, lupus...
- Individuals who are known to have allergic reactions, hypersensitivity reactions, intolerance, or contraindications to any component of PRG-1801 or...
See the full eligibility criteria
Who can join
- Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
- If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL/minute/1.73 m2;
- The following test values within 3 days before the collection of mononuclear cells meet the following standards:
- Absolute lymphocyte count: ≥ 0.5 × 10 \^ 9/L [The use of granulocyte colony-stimulating factor (G CSF) is allowed, but people are not allowed to receive this supportive treatment within 7 days before the screening...
- Absolute neutrophil count: ≥ 1.0 × 10 \^ 9/L [The use of granulocyte colony-stimulating factor (G-CSF) is allowed, but people are not allowed to receive this supportive treatment within 7 days before the screening...
- Platelets: Subject platelet count ≥ 50 × 10 \^ 9/L (people are not allowed to receive blood transfusion support within 7 days before the screening period laboratory examination);
- Hemoglobin: ≥ 8.0 g/dL (allowing the use of recombinant human erythropoietin) [people have not received red blood cell (RBC) infusion within 7 days prior to the screening period laboratory examination];
- Creatinine clearance rate: (CrCl) or glomerular filtration rate (GFR) (Cockcroft Gault formula) ≥ 30 mL/min;
- Total bilirubin (serum): Total bilirubin (serum) ≤ 1.5 × ULN; Blood bilirubin\>1.5 × Gilbert people from ULN can be enrolled with the consent of the sponsor
- AST and ALT: ≤ 3.0 × ULN;
- Plasma prothrombin time (PT), international standardized ratio (INR), partial prothrombin time (APTT): PT ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN, INR ≤ 1.5 × ULN
- Willing to sign an informed consent form.
- \- for refractory ANCA-associated vasculitis ①According to the 2022ACR/EULAR criteria, diagnosed with AAV (GPA or MPA subtype), who has not achieved remission (BVAS score of 0) for ≥ 3 months after receiving...
- \- for refractory LN
- According to the 2019 American Society of Rheumatology (ACR) criteria, diagnosed with systemic lupus erythematosus, within 6 months prior to infusion, confirmed by renal tissue biopsy according to the 2003 International...
What rules you out
- -people who meet any of the following criteria should be excluded from this study:
- Pregnant or lactating women;
- If combined with alveolar hemorrhage, invasive pulmonary ventilation is required;
- Refractory GPA and MPA: Combined with other autoimmune diseases involving multiple organ systems, such as EGPA, SLE, IgA vasculitis (Henoch Schönlein), rheumatoid arthritis, inflammatory myositis, anti-glomerular...
- Difficult to treat LN: severe extrarenal clinical manifestations such as lupus encephalopathy, pulmonary hemorrhage, lupus myocarditis, lupus enteritis, and lupus crisis; Other autoimmune diseases other than combined...
- Individuals who are known to have allergic reactions, hypersensitivity reactions, intolerance, or contraindications to any component of PRG-1801 or drugs that may be used in the study (including fludarabine...
- A history of malignant tumors within 5 years (① people with cervical carcinoma in situ who have been completely removed and have not experienced recurrence or metastasis for at least 3 years may participate in this...
- Obvious evidence of cardiovascular disease as follows: a N-terminal B-type natriuretic peptide (NT proBNP)\>8500ng/L; b. The New York Heart Association (NYHA) classifies heart failure as Grade IV; c. Patients who...
- Received the following medication treatment within the prescribed time before single collection: ① Received B cell depletion therapy such as rituximab within 24 weeks; ② Received biological agents (such as TNF) within 4...
- Vaccinate with live/attenuated vaccines within 4 weeks prior to single collection or during the study period;
- Chronic and active hepatitis B ( the HBV DNA test is higher than 500IU/ml), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, or syphilis infection;
- There is an active infection that requires intravenous injection of antibiotics or hospitalization treatment;
- Major surgery or surgical treatment caused by any reason within 4 weeks prior to enrollment;
- Any serious and/or uncontrollable comorbidities that the researcher believes may interfere with the evaluation during the research process;
- Participated in other intervention clinical trials within 3 months prior to enrollment or within 5 drug half-lives (whichever is longer);
- Other conditions determined by the researcher as unsuitable for lymphocyte clearance or cell infusion, or other unsuitable patients for study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.