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Safety and early efficacy of TranspoCART19 CAR‑T CD19 therapy in patients with refractory lupus nephritis (Phase I‑IIa)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients with lupus nephritis that has not improved with standard medicines, meaning the disease is stubborn or “refractory.” The investigational treatment is called TranspoCART19, which is a form of CAR‑T CD19 therapy. This therapy uses a patient’s own immune cells that are altered in a laboratory and then given back through an intravenous (through a vein) infusion to target the disease‑causing cells.

The purpose of the study is to evaluate the safety and tolerability of this therapy in the early weeks after it is given. Participants will undergo a screening process, receive a single infusion of the cell product, and then be closely observed in the clinic for about a month with regular check‑ups and simple tests to watch for any side effects or reactions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline evaluation

    After joining the study, a series of medical examinations are performed to document the current condition of the kidneys and overall health.

    Blood tests, urine tests, and imaging studies are taken to measure kidney function and disease activity.

    refractory lupus nephritis is explained as kidney inflammation caused by lupus that has not improved with standard treatments.

  2. Step 2

    Pre‑infusion preparation

    The patient meets with the clinical team to review the upcoming procedure and to confirm eligibility for the infusion.

    Any required laboratory values are confirmed as within the range needed to safely receive the therapy.

  3. Step 3

    Infusion of transpocart19

    On day 0, the study medication transpocart19 is given by intravenous administration, which means the product is delivered directly into a vein.

    The medication is a cell suspension for infusion, a preparation that contains engineered immune cells designed to target the disease.

    The exact amount of cells is determined by the study protocol and is delivered as a single infusion.

    No repeated dosing is scheduled; the infusion is a one‑time event.

  4. Step 4

    Early post‑infusion monitoring (day 0‑28)

    The patient is observed closely for the first 28 days after the infusion.

    Regular clinic visits are scheduled to check vital signs, perform blood tests, and assess any side effects.

    The primary focus is to evaluate safety and tolerability of the therapy during this period.

  5. Step 5

    Extended monitoring (day 29‑42, if needed)

    If the patient experiences prolonged low blood cell counts, known as cytopenias, monitoring continues until day 42.

    Additional blood tests and clinical assessments are performed to ensure recovery of blood cell levels.

  6. Step 6

    Follow‑up assessments

    After the monitoring period, the patient attends scheduled follow‑up visits to evaluate longer‑term safety and any signs of improvement in kidney function.

    These visits may include repeat laboratory testing and clinical evaluation.

Who can join the trial?

12 criteria

  • Be able to understand the study information and sign a form showing informed consent, which means you agree to take part after knowing what will happen.
  • Have good vein access and no reason why a leukapheresis (a procedure that collects specific blood cells) cannot be done.
  • Have received all routine vaccinations and any extra shots recommended for people with weakened immune systems, including a full vaccination against SARS‑CoV‑2 (the virus that causes COVID‑19), before or during the screening period.
  • Be able to read and fully understand the patient information sheet, agree to join the study, and follow all study visits and procedures.
  • For women who could become pregnant, a negative blood or urine pregnancy test is required at screening, before conditioning, and before the infusion, and you must use a highly effective contraceptive method for the whole study. For sexually active men, you must use a condom from the start of the study until at least 12 months after the treatment and until special cells are no longer found in two consecutive blood tests; you also must not donate semen during that time, even if you are vasectomised.
  • Be between 18 and 65 years old and have a diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR (European League Against Rheumatism/American College of Rheumatology) classification criteria.
  • At screening, have a positive antinuclear antibody (ANA) test (titer >1:80) or a positive test for anti‑double‑stranded DNA (anti‑dsDNA) or anti‑Smith (anti‑Sm) antibodies, which are blood tests that show lupus activity.
  • Have a kidney (renal) biopsy performed within the last 6 months that shows class III or IV proliferative lupus nephritis (with or without class V), confirmed as active disease by the 2018 ISN/RPS (International Society of Nephrology/Renal Pathology Society) classification.
  • Show evidence that the lupus kidney disease is refractory (does not respond) after at least three months of triple immunosuppressive therapy, or after six months if triple therapy cannot be used, using full‑dose medications such as cyclophosphamide, mycophenolic acid, tacrolimus, cyclosporine, voclosporin, azathioprine, methotrexate, rituximab, belimumab, obinutuzumab, or anifrolumab.
  • Have an estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m² or higher, calculated with the CKD‑EPI (Chronic Kidney Disease Epidemiology Collaboration) equation, at least once during screening. This measures how well the kidneys filter waste.
  • Show a urine protein-to-creatinine ratio (UPCR) greater than 0.7 g/g (or urine albumin-to-creatinine ratio greater than 0.5 g/g) in a spot urine sample, or protein loss in urine (proteinuria) greater than 0.7 g per 24 hours (or albumin greater than 0.5 g per 24 hours), together with active lupus nephritis on biopsy. This indicates excess protein leaking into the urine.
  • Be taking an ACE inhibitor, an ARB (angiotensin receptor blocker), and/or a mineralocorticoid receptor antagonist (with or without an SGLT2 inhibitor) for at least three months before screening, and the dose must have been stable for at least two weeks. These medicines help protect the kidneys and control blood pressure.

Who cannot join the trial?

25 criteria

  • If you have serious heart problems, such as a weakened pumping ability measured by a left ventricular ejection fraction below 50% (or below 40% if the weakness is caused by lupus), you cannot join the study.
  • If you have serious liver problems, such as high liver enzymes (ALT or AST more than 1.5 times the normal limit) or high bilirubin (more than 1.5 times normal), you cannot join, except in specific situations described by the investigators.
  • If your blood clotting test (INR) is higher than 1.5, you cannot join.
  • If your bone marrow is not making enough blood cells (for example, neutrophils ≤1000/µL, platelets ≤75,000/µL, white blood cells ≤3000/µL, lymphocytes ≤300/µL, or hemoglobin ≤8 g/dL), you cannot join.
  • If your oxygen level measured by a finger clip (pulse oximeter) is below 92% without supplemental oxygen, you cannot join.
  • If you are a sexually active male and are unwilling to use condoms for at least 12 months after the treatment and until tests show no CAR‑T cells remain, you cannot join.
  • If you have taken part in another experimental drug study within the last 90 days, or received any non‑approved treatment within the last 4 weeks (or the time it takes the drug to leave your body), you cannot join.
  • If you are unable or unwilling to sign the informed consent form or to attend the required study visits, you cannot join.
  • If you are expected to start dialysis or another form of kidney‑replacement therapy during the study, or if your kidney function (eGFR) is below 30 mL/min/1.73 m², you cannot join.
  • If you have an active infection that needs treatment at the time of screening or before the preparation phase (lymphodepletion), you cannot join.
  • If you test positive for HIV, hepatitis B, hepatitis C, or have active tuberculosis, you cannot join.
  • If you have had a moderate or severe blood clot (thromboembolic event grade 2 or higher) in the past 4 weeks, you cannot join.
  • If you have a confirmed history of Progressive Multifocal Leukoencephalopathy (PML) or brain symptoms that could be PML, you cannot join.
  • If you need a high dose of steroids (prednisone 30 mg per day or more, or an equivalent dose), you cannot join. Lower, stable doses are allowed.
  • If you are allergic (hypersensitive) to any part of the study treatment, including the CAR‑T cells or the medicines used for lymphodepletion, you cannot join.
  • If you have another current or past cancer, you cannot join unless the cancer has been completely gone for more than three years, or it was a non‑melanoma skin cancer or a carcinoma in situ that was fully removed.
  • If you have another autoimmune disease that requires strong immune‑suppressing medication besides lupus, you cannot join.
  • If you have previously received anti‑CD19 CAR‑T cell therapy, you cannot join. Other anti‑CD19 treatments are allowed only if stopped at least 180 days before screening.
  • If you have had a major organ transplant (heart, lung, kidney, liver) or a hematopoietic stem‑cell/bone‑marrow transplant, you cannot join.
  • If you are expected to need major surgery within one year after receiving the study medication, you cannot join.
  • If you received a live vaccine (such as measles, mumps, rubella, yellow fever, etc.) within 30 days before the study medication, you cannot join.
  • If you currently use drugs or alcohol in a way that could prevent you from following the study rules, you cannot join.
  • If you have any other serious or uncontrolled medical or mental health condition that, in the investigator’s opinion, could make the treatment unsafe for you, you cannot join.
  • If you are pregnant or breastfeeding, you cannot join.
  • If you are a woman who could become pregnant and are unwilling to use birth control for the entire study period, you cannot join.
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Investigated drugs

TranspoCART19 is a CAR‑T cell therapy that uses a patient’s own immune cells, which are altered in a laboratory to recognize and attack cells that carry the CD19 protein. In the trial, these specially engineered cells are given by an intravenous infusion as a liquid suspension. The study aims to find out whether this treatment can be given safely to people whose lupus kidney disease has not improved with other medicines, and to gather early information about its possible benefits.

What is already known about the treatment

TranspoCART19 - The medication is given as an intravenous infusion of a cell suspension, meaning specially modified cells are injected into a vein. It is an experimental therapy that is currently in early clinical trials and not yet approved for routine medical use. Its main use is to treat patients with lupus kidney disease that has not improved with other treatments, by targeting the CD19‑positive B cells that contribute to the condition. It works by engineering the patient’s own immune cells to recognize and destroy those B cells, placing it in the class of CAR‑T cell therapies, a form of personalized immunotherapy.

Investigated diseases

Refractory Lupus Nephritis - Lupus nephritis is kidney inflammation caused by systemic lupus erythematosus. In refractory cases, the condition does not improve with standard medicines, and kidney damage can continue to worsen over time. The disease may cause swelling, protein loss in urine, and reduced kidney function. It often progresses slowly, with periods of flare where symptoms increase. Ongoing inflammation can gradually impair the kidneys' ability to filter blood.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-522449-23-00Protocol codeCART-NELEstimated enrolment10 patientsSponsorInstituto De Investigacion Sanitaria Fundacion Jimenez Diaz

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