Lupus NephritisPhase 1/2CART-NELNCT07799116
Study to Evaluate the Safety and Preliminary Efficacy of CD19 CAR-T Cell Therapy (TranspoCART19) in Patients With Refractory Lupus Nephritis
A Phase 1/2 study testing TranspoCART19 in people with Lupus Nephritis and Lupus Nephritis (LN), run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 8 sites in Spain.
Trial summary
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of CD19 CAR-T cell therapy (TranspoCART19) in adults with refractory lupus nephritis. Lupus nephritis is a serious kidney complication of systemic lupus erythematosus that may not respond adequately to standard treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis, Lupus Nephritis (LN)
- What is being tested?
- TranspoCART19
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesSpain
- Study dates
- 23 Sep 2026to Sep 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to provide written informed consent.
- Adults aged ≥18 and ≤65 years with a diagnosis of systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria.
- Positive antinuclear antibody (ANA) result at a titer >1:80, or positive anti-double stranded DNA (anti-dsDNA), or positive anti-Smith (anti-Sm) antibodies at screening.
- Diagnosis of class III or IV proliferative lupus nephritis, with or without concomitant class V disease, confirmed by renal biopsy demonstrating active lupus nephritis according to the 2018 ISN/RPS classification.
- Evidence of refractory or treatment-resistant lupus nephritis according to GLOSEN criteria.
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² during the screening period.
Show all 12Show fewer
- Urine protein-to-creatinine ratio (UPCR) >0.7 g/g, urine albumin-to-creatinine ratio (UACR) >0.5 g/g, proteinuria >0.7 g/24 h, or albuminuria >0.5 g/24 h at screening with evidence of active lupus nephritis.
- Stable treatment with an ACE inhibitor, angiotensin receptor blocker and/or mineralocorticoid receptor antagonist (with or without an SGLT2 inhibitor) for at least 3 months prior to screening, unless contraindicated or not tolerated.
- Adequate venous access and no contraindication to leukapheresis.
- Women of childbearing potential must have a negative pregnancy test at screening, prior to lymphodepletion and prior to infusion, and must agree to use highly effective contraception. Sexually active men must agree to use condoms and comply with protocol-specified reproductive precautions.
- Completion of recommended vaccinations, including SARS-CoV-2 vaccination/immunization, before study treatment.
- Ability and willingness to comply with all study procedures and follow-up requirements.
Who cannot join
- Planned initiation of renal replacement therapy during the study period or eGFR <30 mL/min/1.73 m².
- Severe organ dysfunction, including:
- Left ventricular ejection fraction (LVEF) <40%.
- Severe cardiac disease, including recent ischemic heart disease, NYHA class III-IV heart failure, uncontrolled arrhythmias, or severe lupus-related cardiac involvement.
- Significant hepatic impairment (ALT or AST >1.5× ULN, total bilirubin >1.5× ULN except specified exceptions, INR >1.5).
- Inadequate hematopoietic reserve (absolute neutrophil count ≤1000/µL, platelets <75,000/µL, leukocytes <3000/µL, lymphocytes ≤300/µL, hemoglobin <8 g/dL).
Show all 27Show fewer
- Oxygen saturation <92% on room air.
- Severe pulmonary disease with compromised respiratory reserve.
- Active infection requiring treatment during screening or before lymphodepletion.
- Positive screening for HIV, hepatitis C virus, hepatitis B virus, or evidence of active tuberculosis.
- Grade ≥2 thromboembolic event within 4 weeks before screening.
- History of progressive multifocal leukoencephalopathy (PML) or symptoms suggestive of PML.
- Requirement for systemic glucocorticoids at doses ≥30 mg/day prednisone equivalent.
- Previous treatment with anti-CD19 CAR-T therapy.
- Known hypersensitivity or contraindication to TranspoCART19, fludarabine, cyclophosphamide, bendamustine, or required concomitant medications.
- Concurrent systemic autoimmune disease requiring immunosuppressive therapy independent of SLE treatment.
- Current or previous malignancy, except adequately treated non-melanoma skin cancer, carcinoma in situ, or malignancy in complete remission for more than 3 years.
- Previous solid organ transplantation, hematopoietic stem cell transplantation, or bone marrow transplantation.
- Planned major surgery within one year after study treatment.
- Receipt of live vaccines within 30 days before administration of the investigational product.
- Current drug or alcohol abuse that may interfere with study participation.
- Any severe or uncontrolled medical or psychiatric condition that, in the investigator's opinion, would increase risk or interfere with study participation.
- Pregnancy or breastfeeding.
- Women of childbearing potential unwilling to use highly effective contraception throughout the study period.
- Sexually active men unwilling to use condoms and follow reproductive precautions required by the protocol.
- Participation in another interventional clinical trial within 90 days before informed consent or receipt of another investigational product within the protocol-specified washout period.
- Inability or unwillingness to provide informed consent or comply with study requirements.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Spain8 sites, 8 recruiting
- Not yet recruiting
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
- Not yet recruiting
Hospital Universitario de León
León, 24008
- Not yet recruiting
Hospital Universitario Fundación Jiménez Diaz
Madrid, 28040
- Not yet recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
- Not yet recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
- Not yet recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, 15706
- Not yet recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
About this study
Official title: A National Multicenter Phase I/IIa Study to Evaluate the Safety and Preliminary Efficacy of CD19 CAR-T Cell Therapy (TranspoCART19) in Patients With Refractory Lupus Nephritis.
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of CD19 CAR-T cell therapy (TranspoCART19) in adults with refractory lupus nephritis. Lupus nephritis is a serious kidney complication of systemic lupus erythematosus that may not respond adequately to standard treatments.
The main questions this study aims to answer are:
Read more
- Is TranspoCART19 safe and tolerable in patients with refractory lupus nephritis?
- Can TranspoCART19 induce complete or partial clinical and immunological remission?
Participants will:
- Undergo leukapheresis to collect immune cells for manufacturing TranspoCART19.
- Receive lymphodepleting chemotherapy before treatment.
- Receive a single fractionated infusion of TranspoCART19.
- Attend regular follow-up visits for safety, disease activity, kidney function, immune response, and quality-of-life assessments for up to 24 months, with long-term safety follow-up after study completion.
Read the detailed description
This is a Phase I/IIa, academic, multicenter, open-label, single-arm clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of TranspoCART19 in adult patients with refractory lupus nephritis.
TranspoCART19 is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy manufactured using Sleeping Beauty transposon technology. The CAR construct incorporates an anti-CD19 FMC63 single-chain variable fragment, a 4-1BB co-stimulatory domain, a CD3ζ signaling domain, and a truncated human epidermal growth factor receptor (hEGFRt) safety switch.
Eligible participants will undergo leukapheresis for collection of peripheral blood mononuclear cells. Following manufacturing of the investigational product, participants will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, or bendamustine when clinically indicated, prior to administration of TranspoCART19.
TranspoCART19 will be administered intravenously at a target dose of 1 × 10^6 CAR-T cells/kg body weight using a fractionated infusion strategy consisting of 10%, 30%, and 60% dose fractions. Participants will remain under close monitoring for early and late treatment-related toxicities.
The primary objective is to evaluate the safety and tolerability of TranspoCART19 during the early post-infusion period. Safety assessments include adverse events, serious adverse events, cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), severe infections, prolonged cytopenias, and hypogammaglobulinemia.
Secondary objectives include evaluation of clinical, renal, histological, and immunological responses; hematologic and immune reconstitution; CAR-T cell persistence and kinetics; corticosteroid and immunosuppressive treatment withdrawal; systemic lupus erythematosus disease activity; and health-related quality of life.
Approximately 10 participants will be enrolled. Participants will be followed for 24 months after infusion, and long-term safety monitoring will continue for up to 15 years in accordance with recommendations for genetically modified cellular therapies.
- Conditions
- Lupus Nephritis, Lupus Nephritis (LN)
- Being tested
- TranspoCART19
- Keywords
- Refractory Lupus Nephritis, Systemic Lupus Erythematosus, CD19 CAR-T, TranspoCART19, Cell Therapy Mostrar, CAR T-Cell Therapy, Autoimmune Disease, Lupus, Immunotherapy
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranspoCART19Biological
Autologous CD19-directed CAR-T cell therapy administered following lymphodepleting chemotherapy. After leukapheresis and manufacturing, participants receive TranspoCART19 as a fractionated intravenous infusion (10%, 30%, and 60% of the target dose) at a total target dose of 1 × 10^6 CAR-T cells/kg body weight. The product is manufactured using Sleeping Beauty transposon technology and consists of genetically modified T lymphocytes expressing an anti-CD19 chimeric antigen receptor.
| Study group | Role | What they receive |
|---|---|---|
| TranspoCART19 | Experimental | Participants with refractory lupus nephritis will undergo leukapheresis for manufacturing of autologous TranspoCART19 cells, followed by lymphodepleting chemotherapy and administration of TranspoCART19 as a fractionated intravenous infusion at a target dose of 1 × 10^6 CAR-T cells per kg. Receives: Biological: TranspoCART19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events and Serious Adverse Events Following TranspoCART19 Infusion.
Assessment of safety and tolerability based on the incidence and severity of adverse events, serious adverse events, unacceptable toxicity, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, severe infections, prolonged cytopenias, and hypogammaglobulinemia.
Measured: Day 0 through Day 28 after infusion (extended through Day 42 for prolonged cytopenias).
Secondary outcomes (20)
Number of Participants Achieving Complete or Partial Clinical and Immunological Remission.
Proportion of participants achieving complete or partial clinical and immunological remission following TranspoCART19 infusion.
Measured: Day 56 after TranspoCART19 infusion.
Number of Participants With Adverse Events and Serious Adverse Events During Long-Term Follow-up.
Incidence of adverse events, serious adverse events, vital sign abnormalities, physical examination findings, and laboratory abnormalities during long-term follow-up.
Measured: Baseline through Year 2
Change From Baseline in Hematopoietic and Immunological Reconstitution Parameters.
Changes from baseline in hemoglobin, leukocyte count, platelet count, and immune cell subpopulations including CD3+, CD4+, CD8+, CD19+ B cells, CAR-T cells, NK cells, and NKT cells.
Measured: Baseline through 24 months after infusion
Number and Percentage of Circulating CD19 CAR-T Cells
Number and percentage of circulating CD19 CAR-T cells in peripheral blood and their relationship with clinical response and adverse events.
Measured: Baseline through 24 months after infusion
Change From Baseline in Serum Immunological Activity Markers.
Changes from baseline in ANA, anti-dsDNA, anti-histone, anti-SSA/Ro52, anti-SSB/La, anti-Sm, C3, C4, C1q, CH50, soluble BAFF, and total IgG levels.
Measured: Baseline through 24 months after infusion
Change From Baseline in Renal Disease Activity Parameters.
Changes from baseline in estimated and measured glomerular filtration rate, microhematuria, proteinuria, albuminuria, and proportions of participants achieving complete or partial renal remission.
Measured: Baseline through 24 months after infusion
Change From Baseline in Renal Histological Disease Markers
Changes in lupus nephritis activity index and chronicity indicators assessed by kidney biopsy, including immunohistochemical and immunofluorescence markers.
Measured: Baseline, Day 168, and Day 365
Time to Complete or Partial Renal Clinical Remission
Time from TranspoCART19 infusion to achievement of complete or partial renal clinical remission.
Measured: Baseline through 24 months after infusion
Reduction or Discontinuation of Corticosteroids and Immunosuppressive Therapy
Proportion of participants receiving prednisone doses of 5 mg/day or less or becoming free of immunosuppressive therapy and time required to achieve these outcomes.
Measured: Baseline through 24 months after infusion
Change From Baseline in Systemic Lupus Erythematosus Disease Activity
Changes from baseline in SLEDAI-2K
Measured: Baseline through 24 months after infusion
Change From Baseline in Systemic Lupus Erythematosus Disease Activity
Changes from baseline in BILAG-2004
Measured: Baseline through 24 months after infusion
Change From Baseline in Systemic Lupus Erythematosus Disease Activity
Changes from baseline in Physician Global Assessment
Measured: Baseline through 24 months after infusion
Change From Baseline in Systemic Lupus Erythematosus Disease Activity
Changes from baseline in SLE Flare Index
Measured: Baseline through 24 months after infusion
Change From Baseline in Systemic Lupus Erythematosus Disease Activity
Changes from baseline in DORIS remission criteria.
Measured: Baseline through 24 months after infusion
Number of Participants Achieving Overall Treatment Response
Proportion of participants achieving overall treatment response defined as clinical remission, histological remission, and immunological remission.
Measured: Day 365 after TranspoCART19 infusion.
Change From Baseline in Health-Related Quality of Life.
Changes from baseline in SF-36v2
Measured: Baseline through 24 months after infusion
Change From Baseline in Health-Related Quality of Life.
Changes from baseline in EQ-5D-5L
Measured: Baseline through 24 months after infusion
Change From Baseline in Health-Related Quality of Life.
Changes from baseline in FACIT-F
Measured: Baseline through 24 months after infusion
Change From Baseline in Health-Related Quality of Life.
Changes from baseline in Patient Global Assessment
Measured: Baseline through 24 months after infusion
Change From Baseline in Health-Related Quality of Life.
Changes from baseline in LupusQoL scores.
Measured: Baseline through 24 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start23 Sep 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Ortiz Arduan, Principal investigator, Hospital Universitario Fundación Jiménez Díaz. IIS-FJD.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799116
- Sponsor's protocol ID
- CART-NEL
- Other IDs
- ICI24/00034, 2025-522449-23-00, 2025
- Acronym
- CART-NEL
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Multicenter Phase I/IIa Study to Evaluate the Safety and Preliminary Efficacy of CD19 CAR-T Cell Therapy (TranspoCART19) in Patients With Refractory Lupus Nephritis.
- ClinicalTrials.gov ID
- NCT07799116
- Acronym / sponsor ID
- CART-NEL / CART-NEL
- Conditions
- Lupus Nephritis, Lupus Nephritis (LN)
- Keywords
- Refractory Lupus Nephritis, Systemic Lupus Erythematosus, CD19 CAR-T, TranspoCART19, Cell Therapy Mostrar, CAR T-Cell Therapy, Autoimmune Disease, Lupus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of CD19 CAR-T cell therapy (TranspoCART19) in adults with refractory lupus nephritis. Lupus nephritis is a serious kidney complication of systemic lupus erythematosus that may not respond adequately to standard treatments.
The main questions this study aims to answer are:
- Is TranspoCART19 safe and tolerable in patients with refractory lupus nephritis?
- Can TranspoCART19 induce complete or partial clinical and immunological remission?
Participants will:
- Undergo leukapheresis to collect immune cells for manufacturing TranspoCART19.
- Receive lymphodepleting chemotherapy before treatment.
- Receive a single fractionated infusion of TranspoCART19.
- Attend regular follow-up visits for safety, disease activity, kidney function, immune response, and quality-of-life assessments for up to 24 months, with long-term safety follow-up after study completion.
Detailed description
This is a Phase I/IIa, academic, multicenter, open-label, single-arm clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of TranspoCART19 in adult patients with refractory lupus nephritis.
TranspoCART19 is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy manufactured using Sleeping Beauty transposon technology. The CAR construct incorporates an anti-CD19 FMC63 single-chain variable fragment, a 4-1BB co-stimulatory domain, a CD3ζ signaling domain, and a truncated human epidermal growth factor receptor (hEGFRt) safety switch.
Eligible participants will undergo leukapheresis for collection of peripheral blood mononuclear cells. Following manufacturing of the investigational product, participants will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, or bendamustine when clinically indicated, prior to administration of TranspoCART19.
TranspoCART19 will be administered intravenously at a target dose of 1 × 10^6 CAR-T cells/kg body weight using a fractionated infusion strategy consisting of 10%, 30%, and 60% dose fractions. Participants will remain under close monitoring for early and late treatment-related toxicities.
The primary objective is to evaluate the safety and tolerability of TranspoCART19 during the early post-infusion period. Safety assessments include adverse events, serious adverse events, cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), severe infections, prolonged cytopenias, and hypogammaglobulinemia.
Secondary objectives include evaluation of clinical, renal, histological, and immunological responses; hematologic and immune reconstitution; CAR-T cell persistence and kinetics; corticosteroid and immunosuppressive treatment withdrawal; systemic lupus erythematosus disease activity; and health-related quality of life.
Approximately 10 participants will be enrolled. Participants will be followed for 24 months after infusion, and long-term safety monitoring will continue for up to 15 years in accordance with recommendations for genetically modified cellular therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TranspoCART19 | Experimental | Biological: TranspoCART19Participants with refractory lupus nephritis will undergo leukapheresis for manufacturing of autologous TranspoCART19 cells, followed by lymphodepleting chemotherapy and administration of TranspoCART19 as a fractionated intravenous infusion at a target dose of 1 × 10^6 CAR-T cells per kg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability and willingness to provide written informed consent.
- Adults aged ≥18 and ≤65 years with a diagnosis of systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria.
- Positive antinuclear antibody (ANA) result at a titer >1:80, or positive anti-double stranded DNA (anti-dsDNA), or positive anti-Smith (anti-Sm) antibodies at screening.
- Diagnosis of class III or IV proliferative lupus nephritis, with or without concomitant class V disease, confirmed by renal biopsy demonstrating active lupus nephritis according to the 2018 ISN/RPS classification.
- Evidence of refractory or treatment-resistant lupus nephritis according to GLOSEN criteria.
Key exclusion criteria (27 listed)
- Planned initiation of renal replacement therapy during the study period or eGFR <30 mL/min/1.73 m².
- Severe organ dysfunction, including:
- Active infection requiring treatment during screening or before lymphodepletion.
- Positive screening for HIV, hepatitis C virus, hepatitis B virus, or evidence of active tuberculosis.
- Grade ≥2 thromboembolic event within 4 weeks before screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TranspoCART19Autologous CD19-directed CAR-T cell therapy administered following lymphodepleting chemotherapy. After leukapheresis and manufacturing, participants receive TranspoCART19 as a fractionated intravenous infusion (10%, 30%, and 60% of the target dose) at a total target dose of 1 × 10^6 CAR-T cells/kg body weight. The product is manufactured using Sleeping Beauty transposon technology and consists of genetically modified T lymphocytes expressing an anti-CD19 chimeric antigen receptor. | Biological | TranspoCART19 |
Primary outcome
Number of Participants With Adverse Events and Serious Adverse Events Following TranspoCART19 Infusion.
Time frame: Day 0 through Day 28 after infusion (extended through Day 42 for prolonged cytopenias).
Assessment of safety and tolerability based on the incidence and severity of adverse events, serious adverse events, unacceptable toxicity, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, severe infections, prolonged cytopenias, and hypogammaglobulinemia.
20 secondary outcomes
Number of Participants Achieving Complete or Partial Clinical and Immunological Remission.
Time frame: Day 56 after TranspoCART19 infusion.
Number of Participants With Adverse Events and Serious Adverse Events During Long-Term Follow-up.
Time frame: Baseline through Year 2
Change From Baseline in Hematopoietic and Immunological Reconstitution Parameters.
Time frame: Baseline through 24 months after infusion
Number and Percentage of Circulating CD19 CAR-T Cells
Time frame: Baseline through 24 months after infusion
Change From Baseline in Serum Immunological Activity Markers.
Time frame: Baseline through 24 months after infusion
Change From Baseline in Renal Disease Activity Parameters.
Time frame: Baseline through 24 months after infusion
Change From Baseline in Renal Histological Disease Markers
Time frame: Baseline, Day 168, and Day 365
Time to Complete or Partial Renal Clinical Remission
Time frame: Baseline through 24 months after infusion
Reduction or Discontinuation of Corticosteroids and Immunosuppressive Therapy
Time frame: Baseline through 24 months after infusion
Change From Baseline in Systemic Lupus Erythematosus Disease Activity
Time frame: Baseline through 24 months after infusion
Change From Baseline in Systemic Lupus Erythematosus Disease Activity
Time frame: Baseline through 24 months after infusion
Change From Baseline in Systemic Lupus Erythematosus Disease Activity
Time frame: Baseline through 24 months after infusion
Change From Baseline in Systemic Lupus Erythematosus Disease Activity
Time frame: Baseline through 24 months after infusion
Change From Baseline in Systemic Lupus Erythematosus Disease Activity
Time frame: Baseline through 24 months after infusion
Number of Participants Achieving Overall Treatment Response
Time frame: Day 365 after TranspoCART19 infusion.
Change From Baseline in Health-Related Quality of Life.
Time frame: Baseline through 24 months after infusion
Change From Baseline in Health-Related Quality of Life.
Time frame: Baseline through 24 months after infusion
Change From Baseline in Health-Related Quality of Life.
Time frame: Baseline through 24 months after infusion
Change From Baseline in Health-Related Quality of Life.
Time frame: Baseline through 24 months after infusion
Change From Baseline in Health-Related Quality of Life.
Time frame: Baseline through 24 months after infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alberto Ortiz Arduan principal investigator
Hospital Universitario Fundación Jiménez Díaz. IIS-FJD.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TranspoCART19 in people with Lupus Nephritis and Lupus Nephritis (LN), run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucia Llanos (91 5504800 ext. 3214, lucia.llanos@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events and Serious Adverse Events Following TranspoCART19 Infusion. (time frame: Day 0 through Day 28 after infusion (extended through Day 42 for prolonged cytopenias).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.