ClinicalTrials.gov record NCT06497387
Safety and Efficacy of PRG-1801 for Refractory Lupus Nephritis and IgG4-Related Disease
Safety and Efficacy of PRG-1801(BCMA-targeting CAR-T Cells) for Refractory Lupus Nephritis and IgG4-Related Disease
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.
An early-phase, interventional trial testing PRG-1801 (BCMA-targeting CAR‑T cells) in people with refractory lupus nephritis or refractory IgG4‑related disease. The study uses a sequential dose-exploration (three planned dose levels) followed by a dose-expansion phase to evaluate safety and activity. Participants are monitored with clinical assessments and blood tests over follow-up visits up to 24 months.
What it is studying. The study is testing the safety and tolerability of PRG-1801 CAR‑T cell infusion, seeking a safe dose, and measuring effects on disease activity and immune markers in people with refractory lupus nephritis or IgG4‑related disease.
What the researchers hope to learn. To determine a safe dose of PRG-1801 infusion; to record and characterize adverse events; to measure effects on lupus nephritis and IgG4‑RD disease activity, relapse timing, and immunologic markers; and to describe pharmacokinetic and pharmacodynamic behavior of the CAR‑T cells.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
A Clinical Study on the Safety and Effectiveness of BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Lupus Nephritis and IgG4-Related Disease.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- PRG-1801
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- A. Age ≥ 18 years old; B. If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL/minute/1.73 m2;
- C. 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 subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination];
- Absolute neutrophil count: ≥ 1.0 × 10 \^ 9/L [The use of granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination];
- Platelets: Subject platelet count ≥ 50 × 10 \^ 9/L (subjects 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) [subjects 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 subjects 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 reproductive age at the time of screening and before cell infusion must be negative.
- 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 the study.
- for refractory LN
- A. 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 Society of Nephrology (ISN)/Society of Nephropathology (RPS) criteria as active, proliferative lupus nephritis (LN), type III or IV, or type III/IV combined with type V, or type V. And have received standard treatment that is ineffective or relapses after disease remission.
- B. Positive anti-nuclear antibodies (ANA) and/or anti-dsDNA antibodies during the screening period.
- C. 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
- A. According to the 2019 ACR/EULAR criteria, diagnosed with IgG4-RD; B. The clinical manifestations were recurrent or refractory IgG4-RD; C. IgG4-RD response index (RI) ≥2, the disease is in the active stage; D. meet the clinical phenotype of Mikulitz/systemic
Exclusion criteria
- Subjects 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 (① subjects 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 study. ② subjects with basal cell or squamous cell carcinoma who have been completely removed and have not experienced recurrence for at least 3 years may participate in this study);（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 has been treated therapeutically, ③ Prostate cancer that has been treated with radical prostatectomy or curative radiation therapy for more than 3 years prior to screening has no known recurrence and is not currently receiving treatment；④have had surgery for thyroid cancer, and have not evidence of active disease）;
- 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 reinfusion;
- 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 received hospitalization for unstable angina or myocardial infarction within 6 months prior to the first administration, or patients who received percutaneous cardiac intervention and received the most recent stent placement within 6 months or coronary artery bypass grafting within 6 months;
- People who have a known allergy, hypersensitivity, intolerance, or contraindication to any component of PRG-1801 or the drugs that may be used in the study, including fludarabine, cyclophosphamide, tolumab, or albumin, or who have had a prior severe allergic reaction;
- 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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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 have collection of mononuclear cells (blood cell collection), undergo lymphocyte‑clearing conditioning, and receive an infusion of PRG‑1801 at a dose determined by the study's dose‑finding phase. They will have frequent blood tests for safety, pharmacokinetics/pharmacodynamics and immune markers, plus clinical exams and disease activity assessments (including urine and kidney function tests) at scheduled visits up to 24 months after infusion. Women will have pregnancy tests before infusion and fertile participants must use contraception for 1 year. The study includes a dose‑exploration phase (three dose levels) followed by a dose‑expansion phase for selected doses.
How the study is structured. Interventional early-phase 1 trial. Participants receive PRG-1801 (BCMA-targeting CAR‑T) at one of three planned dose levels in a dose-exploration (sequential) phase; after a safe dose is identified a dose-expansion phase enrolls additional participants at that dose. Open-label (no masking) with one experimental treatment arm. Participants have repeated clinical assessments, laboratory and immunologic testing, pharmacokinetic/pharmacodynamic measurements, and disease activity scores during follow-up up to 24 months.
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
- July 2024 (estimated)
- Primary completion
- July 2027 (estimated)
- Study completion
- July 2028 (estimated)
- Target enrollment
- 30 participants (estimated)
- Last updated on registry
- Jul 11, 2024
- 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
- Tongji Hospital
- Principal investigator
- Lingli Dong, Professor of the department of rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Tongji Hospital - Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
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.
- Lingli Dong, MD 📞 02783665519 ✉ tjhdongll@163.com
- Ziwei Hu, MD 📞 02783665518 ✉ 836048368@qq.com
Participating sites (1)
- Tongji HospitalRecruiting
Wuhan, Hubei, 430030 · China
- Lingli Dong, MD · 02783665519 · tjhdongll@163.com
- Ziwei Hu · 02783665518 · 836048368@qq.com
Terms used on this page · explanations by MedicalUpdates.ai
- 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.
- 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.
- glomerular filtration rate
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- screening period
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- 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.
- Creatinine clearance
- A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
- × ULN
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- sponsor
- The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
- 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.
- study 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.
- 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.
- standard treatment
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- immunosuppressant
- 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.
- corticosteroid
- 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.
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- 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.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
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.
← Back to clinical trials