Study to Evaluate the Safety and Preliminary Efficacy of CD19 CAR-T Cell Therapy (TranspoCART19) in Patients With Refractory Lupus Nephritis

NCT07799116 | Recruiting Phase 1

• 4 other identifiers: CART-NELICI24/000342025-522449-23-002025
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 8

Brief 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. 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.

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; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Day 56 after TranspoCART19 infusion.

• Number of Participants With Adverse Events and Serious Adverse Events During Long-Term Follow-up.

  Baseline through Year 2

• Change From Baseline in Hematopoietic and Immunological Reconstitution Parameters.

  Baseline through 24 months after infusion

• Number and Percentage of Circulating CD19 CAR-T Cells

  Baseline through 24 months after infusion

• Change From Baseline in Serum Immunological Activity Markers.

  Baseline through 24 months after infusion

Study Arms (1)

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.

Biological: TranspoCART19

Interventions

TranspoCART19 BIOLOGICAL

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.

TranspoCART19

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (8)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

NOT YET RECRUITING

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Galicia, 15706, Spain

NOT YET RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario de León

León, 24008, Spain

NOT YET RECRUITING

Hospital Universitario Fundación Jiménez Diaz

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

NOT YET RECRUITING

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

NOT YET RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• Alberto Ortiz Arduan

  Hospital Universitario Fundación Jiménez Díaz. IIS-FJD.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Llanos

CONTACT

91 5504800; lucia.llanos@quironsalud.es

Eva Cerezo

CONTACT

91 5504800; eva.cerezo@quironsalud.es

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 2, 2026
• Study Start: September 23, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)