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Tests treatment safety and results for Lupus Nephritis
Official title Safety and Efficacy of PRG-2311 for Refractory Lupus Nephritis and IgG4-Related Disease
ClinicalTrials.gov ID: NCT06497361
What this study is testing
What is PRG-2311?
PRG-2311 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
- A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Lupus Nephritis and IgG4-Related Disease.
- 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 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 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;
- A history of malignant tumors within 5 years （①Carcinoma in situ of the cervix that has undergone curative treatment for more than 12 months prior to...
- Received any B-cell depletion biologic therapy (for example, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab, etc) in the 6 months...
- Received immunosuppressant therapy within 3 days prior to CAR-T reinfusion, or systemic corticosteroid therapy (\>10 mg/ day of prednisone or...
- Received live vaccine or live therapeutic STDS within 2 weeks prior to screening;
See the full eligibility criteria
Who can join
- Age ≥ 18 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.
- Fertile men and women of childbearing age must agree to use effective contraception from the time they sign an informed consent and up to 1 year after the study drug is used. Blood pregnancy tests for women of...
- The patients or their guardians agree to participate in the clinical study and sign the informed consent, indicating that they understand the purpose and procedure of the clinical study and are willing to participate in...
- 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...
- Positive anti-nuclear antibodies (ANA) and/or anti-dsDNA antibodies during the screening period.
- The SLE Disease Activity Index (SLEDAI-2000) score during the screening period is ≥ 8. SLEDAI-2000 clinical score ≥ 6 points, but low complement and/or anti ds-DNA positivity can be selected.
- for refractory IgG4-RD
- According to the 2019 ACR/EULAR criteria, diagnosed with IgG4-RD;
- The clinical manifestations were recurrent or refractory IgG4-RD;
- IgG4-RD response index (RI) ≥2, the disease is in the active stage;
- meet the clinical phenotype of Mikulitz/systemic
What rules you out
- people who meet any of the following criteria should be excluded from this study:
- Pregnant or lactating women;
- A history of malignant tumors within 5 years （①Carcinoma in situ of the cervix that has undergone curative treatment for more than 12 months prior to screening, ②Basal cell or squamous cell carcinoma of the skin that...
- Received any B-cell depletion biologic therapy (for example, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab, etc) in the 6 months prior to CAR-T reinfusion, unless B-cell recovery was demonstrated;
- Received immunosuppressant therapy within 3 days prior to CAR-T reinfusion, or systemic corticosteroid therapy (\>10 mg/ day of prednisone or equivalent doses of other corticosteroids) within 3 days prior to CAR-T...
- Received live vaccine or live therapeutic STDS within 2 weeks prior to screening;
- The presence of chronic and active hepatitis B (except for HBV DNA testing below 500IU/ml), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, or syphilis infection;
- With an active infection that requires intravenous antibiotics or hospitalization;
- 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...
- People who have a known allergy, hypersensitivity, intolerance, or contraindication to any component of PRG-2311 or the drugs that may be used in the study, including fludarabine, cyclophosphamide, tolumab, or albumin...
- Patients with other conditions determined by the investigator to be unsuitable for lymphocyte clearance or cell infusion, or who are otherwise unsuitable for study participation.
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 and older. Healthy volunteers may be eligible. 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.