Safety and Preliminary Efficacy of TranspoCART19 Cell Therapy in Patients with Refractory Lupus Nephritis (Phase I‑IIa)

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What is this study about?

The study involves adults with lupus nephritis that has not responded to usual medicines, a condition in which the immune system attacks the kidneys and causes swelling, protein loss in urine, and reduced kidney function. The experimental treatment is a cell‑based product named TranspoCART19, which is a form of CAR‑T CD19 therapy given by an intravenous infusion to help the immune system target the problematic cells.

The purpose of the study is to evaluate the safety and tolerability of this therapy during the first weeks after it is given. Participants receive a single infusion and remain under close observation for about four weeks, with additional check‑ups extending to day 42 if low blood cell counts (cytopenias) persist. After the initial monitoring period, follow‑up visits continue for several months to watch for any delayed effects.

Safety assessments include regular blood tests to check for changes in cell counts, kidney function tests to see how well the kidneys are working, and physical examinations. If any side effects appear, they are treated promptly according to standard medical practice.

1 enrollment and consent

after joining the study, a written consent form is signed to confirm participation.

basic health information and medical history are recorded.

2 baseline assessment

initial examinations are performed, including blood tests, kidney function tests, and checks for eligibility.

the results confirm that the patient meets the criteria for refractory lupus nephritis.

3 infusion preparation

the study medication, transpocart19, is prepared as a cell suspension ready for infusion.

4 infusion (day 0)

on day 0 the patient receives transpocart19 by intravenous administration (delivery into a vein).

the specific dose and volume are determined by the study protocol; no additional medication schedule is required.

5 immediate post‑infusion monitoring

the patient remains in the clinic for observation during the first 24 to 48 hours.

vital signs, blood counts, and kidney function are checked regularly to detect any early reactions.

6 scheduled follow‑up visits (day 1–28)

follow‑up appointments are scheduled on day 1, day 3, day 7, day 14, day 21, and day 28.

at each visit the patient undergoes safety assessments, including blood tests and kidney function checks.

7 extended monitoring (up to day +42 if needed)

if low blood cell counts or other safety concerns persist, monitoring continues beyond day 28 up to day +42.

additional laboratory tests are performed as required.

8 final evaluation

at the end of the monitoring period the patient has a comprehensive safety review.

the study team records any adverse events and assesses overall tolerability of the therapy.

Who Can Join the Study?

Be able to understand the study information, agree to take part, and sign the consent form (informed consent).
Have good veins for blood collection and no medical reason that would stop a procedure called leukapheresis (a process that removes certain white blood cells from your blood).
Have received all routine vaccinations, including the full COVID‑19 vaccine series, before or during the screening period.
Be willing and able to read and understand the patient information sheet, give consent, and follow all study visits and tests.
If you are a woman who could become pregnant, you must have a negative pregnancy test at three points (screening, before conditioning, and before the infusion) and agree to use a highly effective birth‑control method for the whole study.
If you are a sexually active man, you must use a condom from the day you join the study until at least 12 months after the treatment and until lab tests show the therapy cells are gone; you also must not donate semen during this time, even if you have had a vasectomy.
Be between 18 and 65 years old and have a diagnosis of systemic lupus erythematosus (SLE) that meets the 2019 classification criteria.
Show a positive test for one of the following lupus‑related antibodies at screening: antinuclear antibody (ANA) with a titre higher than 1:80, or anti‑double‑stranded DNA (anti‑dsDNA), or anti‑Smith (anti‑Sm) antibodies.
Have a kidney biopsy (a small sample of kidney tissue) done within the past 6 months that shows class III or IV proliferative lupus nephritis (with or without class V). If the biopsy is older, a new one may be done during screening, or active kidney disease must be proven by other tests.
Have lupus nephritis that is considered refractory (does not improve) – meaning protein loss in urine or kidney function got worse after at least three months of three different strong immune‑suppressing medicines, or after at least six months of full‑dose therapy with steroids and at least two of the listed drugs (such as cyclophosphamide, mycophenolic acid, tacrolimus, cyclosporine, azathioprine, methotrexate, rituximab, belimumab, etc.).
Have an estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m² or higher (a measure of how well the kidneys filter blood) at least once during screening.
Show significant protein loss in urine at screening, measured as a urine protein‑to‑creatinine ratio (UPCR) greater than 0.7 g/g (or urine albumin‑to‑creatinine ratio >0.5 g/g), or a 24‑hour urine protein amount over 0.7 g (or albumin ≥0.5 g) together with active lupus kidney disease on biopsy.
Be taking an ACE inhibitor, an ARB, 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 unless you cannot tolerate it or have other medical reasons.

Who Cannot Join the Study?

Severe organ problems such as a weak heart (low left ventricular ejection fraction), liver issues (high liver enzymes ALT/AST or high bilirubin), very low blood cell counts (low neutrophils, platelets, white cells, lymphocytes, or hemoglobin), or low oxygen levels (oxygen saturation below 92% without oxygen) exclude participation.
Sexually active men who are not willing to use condoms for at least 12 months after the treatment and until the therapy cells are no longer detectable cannot join.
Anyone who took part in another experimental drug study within the past 90 days, or received any non‑commercial experimental treatment within the past 4 weeks (or the time equal to five drug half‑lives) is excluded.
People who cannot or will not sign the informed‑consent form or follow the study visits are not eligible.
Planned start of dialysis or other kidney‑replacement therapy during the study, or a kidney function test (eGFR) below 30 mL/min/1.73 m², disqualifies a participant.
Having an active infection that needs treatment at the time of screening or before the preparatory (lymphodepletion) phase excludes you.
Testing positive for HIV, hepatitis B, hepatitis C, or having active tuberculosis at screening makes you ineligible.
Any blood‑clot event (thromboembolic event) of moderate or higher severity (grade 2 or above) within the four weeks before screening disqualifies participation.
A past diagnosis of Progressive Multifocal Leukoencephalopathy (PML) or neurological signs that could indicate PML prevents enrollment.
Needing a high dose of systemic steroids (prednisone ≥ 30 mg per day or equivalent) excludes you; lower stable doses are allowed.
Allergy (hypersensitivity) to any part of the study treatment, including the CAR‑T cells or the drugs used to prepare the body (lymphodepletion), is an exclusion.
Current or recent cancer, unless the cancer has been completely gone for more than three years or is a non‑melanoma skin cancer or fully removed carcinoma in situ, excludes participation.
Having another autoimmune disease that requires its own immune‑suppressing medicines, which could flare if stopped, makes you ineligible.
Previous treatment with anti‑CD19 CAR‑T therapy disqualifies you; other anti‑CD19 treatments are allowed only if stopped at least 180 days earlier.
A history of major organ transplant (heart, lung, kidney, liver) or bone‑marrow/hematopoietic stem‑cell transplant excludes you.
Planning to have a major surgery within one year after receiving the study medication is a reason for exclusion.
Receiving any live vaccine within 30 days before the study drug is administered makes you ineligible.
Current drug or alcohol misuse that could interfere with following the study rules leads to exclusion.
Any other serious or uncontrolled medical or psychiatric condition that, in the investigator’s view, could prevent you from tolerating the therapy or completing the study excludes participation.
Being pregnant or breastfeeding prevents enrollment.
Women who could become pregnant and are not willing to use effective birth‑control methods throughout the study cannot take part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario De Leon	Leon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hbbexmei Uiwuekxchlvfr Hbrnqyzk Tnvmf y Pdgtzg Iyhkxnmi Cwqlan dxexoxbxaotllzfqf (xdxz	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.05.2026

Trial locations

Investigated drugs:

Transpocart19

TranspoCART19 is a type of cell‑based therapy called CAR‑T cell therapy. In this treatment, a patient’s own immune cells (T cells) are taken out, genetically changed in a laboratory so they can recognize a protein called CD19, and then given back to the patient through an IV infusion. The goal is for these engineered cells to find and destroy the immune cells that are causing lupus nephritis, a serious kidney problem that has not responded to other medicines. In the trial, TranspoCART19 is being tested to see if it is safe and how well it works in people with this difficult‑to‑treat form of lupus.

Investigated diseases:

Lupus nephritis

Lupus nephritis – Lupus nephritis is inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus. It develops when immune complexes deposit in the kidney, leading to swelling, protein loss in urine, and reduced kidney filtering ability. Over time the condition can cause worsening kidney function and may progress despite standard therapy, which is described as refractory when it persists or worsens. The disease often follows a pattern of flare-ups, where symptoms increase, followed by periods of relative calm. Continuous activity can lead to gradual loss of kidney performance if not controlled.

Trial ID:

2025-522449-23-00

Protocol code:

CART-NEL

Trial Phase:

Human Pharmacology (Phase I) – Other

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Safety and Preliminary Efficacy of TranspoCART19 Cell Therapy in Patients with Refractory Lupus Nephritis (Phase I‑IIa)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?