Lupus Erythematosus, SystemicPhase 1/2CLEVER-SLENCT07659704
CD19-Directed CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus
A Phase 1/2 study testing Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood Center in people with Lupus Erythematosus, Systemic, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks the body's own tissues and organs. The disease can affect the skin, joints, kidneys, blood cells, brain, and other organs, leading to significant health problems and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood Center
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Oct 2026to 1 Oct 2028
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 50 years, inclusive.
- Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 ACR/EULAR classification criteria.
- Active disease at screening, defined as SLEDAI-2K ≥4 and Physician Global Assessment (PGA) ≥0.5.
- Inadequate response, intolerance, or contraindication to corticosteroids and at least two of the following therapies: azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, belimumab, rituximab, or tacrolimus.
- Adequate organ function, including:
- Hepatic function: AST and ALT ≤3× upper limit of normal (ULN); total bilirubin ≤2× ULN (participants with documented Gilbert syndrome are eligible).
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- Hematologic function: neutrophils ≥1,000/mm³; hemoglobin ≥8 g/dL without transfusion within 14 days; lymphocytes ≥500/mm³; platelets ≥20,000/mm³ without transfusion within 14 days.
- Renal function: estimated creatinine clearance ≥30 mL/min (CKD-EPI).
- Cardiac function: left ventricular ejection fraction ≥40%.
- Pulmonary function: oxygen saturation ≥92% on room air.
- Women of childbearing potential must agree to use highly effective contraception during study participation and for 12 months after CAR-T cell infusion.
- Male participants must agree to use barrier contraception during study participation and for 12 months after CAR-T cell infusion.
- Ability to understand and provide written informed consent.
Who cannot join
- Severe pulmonary hypertension (estimated pulmonary artery systolic pressure >50 mmHg).
- Requirement for systemic anticoagulation at screening.
- Clinically significant cardiovascular disease, including NYHA Class III/IV heart failure, myocardial infarction, unstable arrhythmias, or unstable angina within the previous 6 months.
- Active neurological disease (stroke, epilepsy, or neurodegenerative disorders) within the previous 12 months.
- History of malignancy within 2 years prior to screening, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, or stage I uterine cancer.
- Previous or suspected hemophagocytic lymphohistiocytosis/macrophage activation syndrome.
Show all 16Show fewer
- Active or uncontrolled bacterial, viral, fungal, or other infection.
- Active hepatitis B infection or detectable HBV DNA.
- Active hepatitis C infection or detectable HCV RNA.
- Human immunodeficiency virus (HIV) infection.
- Pregnancy, breastfeeding, or plans to become pregnant during the study or within 12 months after CAR-T cell infusion.
- Major surgery within 4 weeks prior to screening.
- Administration of a live attenuated vaccine within 4 weeks prior to screening.
- Prior allogeneic or autologous hematopoietic stem cell transplantation or prior solid organ transplantation.
- Inability or unwillingness to comply with study procedures and follow-up requirements.
- Any medical condition that, in the investigator's judgment, could compromise participant safety or interfere with study assessments.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Carolina Oliveira Rodrigues, MD, PhD contact
Brazil2 sites
Hospital das Clinicas de Ribeirão Preto (HCFMRP-USP)
Ribeirão Preto, São Paulo, 14048-900
Diego V. Clé, MD, MBA, PhD, +55 16 21019300, terapia@hemocentro.fmrp.usp.br
Maria Carolina Oliveira Rodrigues, MD, PhD, mcarolor@usp.br
Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP)
São Paulo, São Paulo, 05403-010
Eloisa Bonfá, Full Professor, +55 11 30617492, eloisa.bonfa@hc.fm.usp.br
Luciana Seguro, MD, PhD, luciana.seguro@hc.fm.usp.br
About this study
Official title: CD19-targeted Lymphocyte Engineering Validation for the trEatment of Refractory Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks the body's own tissues and organs. The disease can affect the skin, joints, kidneys, blood cells, brain, and other organs, leading to significant health problems and reduced quality of life. Although several treatments are available, some patients continue to have active disease despite receiving standard therapies.
Recent research has shown that B cells, a type of immune cell, play a central role in the development and persistence of SLE. CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy is an innovative treatment that uses a patient's own immune cells, genetically modified to recognize and eliminate B cells. This approach has already shown remarkable success in certain blood cancers and has recently produced encouraging results in patients with severe autoimmune diseases, including SLE.
Read more
The CLEVER-SLE study is a Phase I/II clinical trial designed to evaluate the safety and potential effectiveness of CD19-directed CAR-T cell therapy produced at Ribeirao Preto Blood Bank in patients with SLE who have not responded adequately to conventional treatments. Participants will undergo the collection of their own immune cells, which will be modified in a specialized laboratory to produce CAR-T cells. After receiving preparatory chemotherapy, participants will receive a single intravenous infusion of these CAR-T cells.
The main goal of this study is to evaluate the safety of this treatment. Researchers will also assess its effects on disease activity, symptoms, organ involvement, medication requirements, immune system markers, and the duration of clinical responses. The study aims to determine whether CD19-directed CAR-T cell therapy can provide a new treatment option for patients with refractory SLE and contribute to the development of CAR-T therapies for autoimmune diseases.
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by loss of immune tolerance, production of pathogenic autoantibodies, and immune-mediated tissue injury. The disease can affect virtually any organ system, including the skin, joints, kidneys, hematologic system, cardiovascular system, and central nervous system. Despite major advances in the understanding of disease pathogenesis and the availability of immunosuppressive and biologic therapies, many patients continue to experience persistent disease activity, recurrent flares, progressive organ damage, reduced quality of life, and increased mortality.
B lymphocytes play a central role in the pathogenesis of SLE. Beyond their ability to differentiate into antibody-producing plasma cells, B cells contribute to disease development through antigen presentation, cytokine production, and maintenance of autoreactive immune responses. The persistence of autoreactive B-cell populations is believed to be a key driver of chronic disease activity and treatment resistance.
Several therapeutic strategies targeting B cells have been developed for SLE, including anti-CD20 monoclonal antibodies and inhibitors of B-cell survival pathways. Although these approaches have improved outcomes for many patients, a substantial proportion of individuals fail to achieve sustained remission. One potential limitation of antibody-based therapies is their inability to completely eliminate autoreactive B-cell populations residing within inflamed tissues and specialized immune niches. In contrast, CD19-directed CAR-T cells are living immune effectors capable of expanding in vivo, trafficking to affected tissues, and mediating deep depletion of B cells not only in the peripheral blood but also within sites of ongoing autoimmune inflammation. This broader and more profound tissue-level B-cell depletion may contribute to more durable disease control and potentially restore immune tolerance. In addition, existing therapies often require continuous administration and may be associated with cumulative toxicities, incomplete disease control, or relapse after treatment discontinuation.
CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy represents a novel therapeutic strategy that enables a patient's own T lymphocytes to recognize and eliminate CD19-expressing B cells. This approach has demonstrated unprecedented efficacy in B-cell malignancies and has transformed the treatment landscape of several hematologic cancers. More recently, emerging clinical evidence has suggested that deep B-cell depletion induced by CD19-directed CAR-T cells may also be capable of resetting abnormal immune responses in autoimmune diseases.
Early clinical experiences in patients with severe refractory autoimmune diseases, including systemic lupus erythematosus, have reported rapid and profound reductions in disease activity, sustained clinical remissions, normalization of serological markers, and significant reductions in the need for immunosuppressive medications. These findings have generated considerable interest in the potential application of CAR-T cell therapy beyond oncology and have established a strong scientific rationale for further investigation in autoimmune disorders.
The CAR-T product evaluated in this study consists of autologous T lymphocytes genetically modified to express a chimeric antigen receptor directed against CD19. The product is manufactured at the Ribeirão Preto Blood Center (Hemocentro de Ribeirão Preto), one of the leading academic cell therapy centers in Brazil. This manufacturing platform has previously demonstrated feasibility, safety, and clinical activity in patients with hematologic malignancies and serves as the foundation for the present investigation.
The CLEVER-SLE study was developed to evaluate the use of CD19-directed CAR-T cell therapy manufactured at the Ribeirão Preto Blood Center in patients with refractory systemic lupus erythematosus. The study seeks to expand current knowledge regarding the safety profile and therapeutic potential of CAR-T cells in autoimmune diseases while generating clinical evidence to support the development of advanced cellular therapies for patients with severe disease who have limited treatment options.
By investigating a strategy capable of directly targeting the cellular drivers of autoimmunity, this study aims to contribute to the development of transformative therapies that may achieve sustained disease control and improve long-term outcomes for patients with refractory SLE.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood Center
- Keywords
- Systemic Lupus Erythematosus, SLE, Refractory Systemic Lupus Erythematosus, Lupus Nephritis, CAR-T Cell Therapy, CD19-Directed CAR-T Cells, CD19, Chimeric Antigen Receptor T Cells, B Cell Depletion, B Lymphocytes, Autoimmune Diseases, Cellular Therapy, Advanced Therapy Medicinal Products, Immune Reconstitution, Autologous CAR-T Cells
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood CenterBiological
Autologous CD19-directed chimeric antigen receptor T (CAR-T) cells developed and manufactured at the Ribeirão Preto Blood Center (Hemocentro de Ribeirão Preto, Brazil). T lymphocytes collected by leukapheresis are genetically modified ex vivo using a lentiviral vector to express a CD19-specific chimeric antigen receptor and subsequently expanded under Good Manufacturing Practice (GMP) conditions. Following standard lymphodepleting chemotherapy, participants receive a single intravenous infusion of the autologous CAR-T cell product. The therapy is intended to achieve deep and sustained depletion of CD19-positive B cells implicated in the pathogenesis of systemic lupus erythematosus.
| Study group | Role | What they receive |
|---|---|---|
| Autologous CD19-Directed CAR-T Cells | Experimental | Participants with refractory systemic lupus erythematosus will undergo leukapheresis for the manufacture of autologous CD19-directed CAR-T cells, followed by lymphodepleting chemotherapy and a single intravenous infusion of the CAR-T cell product. Receives: Biological: Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Incidence and maximum grade of CRS and ICANS following infusion of autologous CD19-directed CAR-T cells, assessed according to ASTCT consensus criteria.
Measured: 30 days after CAR-T cell infusion
Secondary outcomes (15)
Incidence of Grade ≥3 Cytopenias
Incidence of grade ≥3 anemia, neutropenia, lymphopenia, and thrombocytopenia according to CTCAE v6.0.
Measured: Up to 90 days after CAR-T cell infusion
Time to Hematologic Recovery
Time to resolution of cytopenias to grade <1.
Measured: Up to 12 months after CAR-T cell infusion
Incidence and Severity of Infections
Cumulative incidence and severity of infections
Measured: Up to 12 months after CAR-T cell infusion
Incidence of Serious Infections
Incidence of grade ≥3 infections according to CTCAE v6.0
Measured: Up to 12 months after CAR-T cell infusion
Changes in Serum Immunoglobulin Levels
Absolute and relative changes in serum IgG, IgA, and IgM concentrations compared with baseline
Measured: Baseline, Day 30, Day 90, Day 180, and Day 360
Incidence of Other CAR-T Cell-Associated Toxicities
Incidence and severity of coagulopathy, immune effector cell-associated hemophagocytic syndrome (IEC-HS), cytomegalovirus reactivation, and local immune effector cell-associated toxicity syndrome (LICATS)
Measured: Up to 12 months after CAR-T cell infusion
Deep Remission Rate
Percentage of participants achieving deep remission, defined as clinical SLEDAI-2K=0 (allowing isolated serological activity), Physician Global Assessment (PGA) ≤0.5, and no requirement for additional immunosuppressants, biologics, small molecules, or corticosteroids after CAR-T cell therapy.
Measured: 6 months after CAR-T cell infusion
SRI-4 Response Rate
Percentage of participants achieving an SRI-4 response, defined as a ≥4-point reduction in SLEDAI-2K score, no new BILAG A score and no more than one new BILAG B score, and no worsening in PGA (increase <0.3 points)
Measured: 6 months after CAR-T cell infusion
Lupus Low Disease Activity State (LLDAS) Achievement Rate
Percentage of participants achieving LLDAS criteria
Measured: 6 and 12 months after CAR-T cell infusion
DORIS Remission Rate
Percentage of participants achieving Definitions Of Remission In SLE (DORIS) criteria
Measured: 6 and 12 months after CAR-T cell infusion
Renal Response Rate
Among participants with active lupus nephritis (proteinuria ≥500 mg/24 hours at baseline), percentage achieving complete renal response or partial renal response
Measured: 6 and 12 months after CAR-T cell infusion
Cutaneous Lupus Response Rate
Among participants with baseline CLASI-Activity score ≥10, percentage achieving CLASI-50 response, defined as ≥50% reduction in CLASI-Activity score from baseline.
Measured: 6 and 12 months after CAR-T cell infusion
Articular Response Rate
Among participants with ≥6 active arthritic joints at baseline, percentage achieving at least 50% reduction in the number of active joints
Measured: 6 and 12 months after CAR-T cell infusion
Anti-dsDNA Serologic Response
Percentage of participants achieving negative anti-double-stranded DNA antibody titers (negative or ≤1:10)
Measured: 6 and 12 months after CAR-T cell infusion
Corticosteroid and Immunosuppressant-Free Remission
Percentage of participants not receiving corticosteroids or immunosuppressive medications
Measured: 6 and 12 months after CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Blood Center of Ribeirao Preto
- Responsible party
- Principal investigator, Diego Villa Clé, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659704
- Sponsor's protocol ID
- HEMO-03-CART
- Acronym
- CLEVER-SLE
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD19-targeted Lymphocyte Engineering Validation for the trEatment of Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07659704
- Acronym / sponsor ID
- CLEVER-SLE / HEMO-03-CART
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Systemic Lupus Erythematosus, SLE, Refractory Systemic Lupus Erythematosus, Lupus Nephritis, CAR-T Cell Therapy, CD19-Directed CAR-T Cells, CD19, Chimeric Antigen Receptor T Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Regional Blood Center of Ribeirao Preto
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 22 Jun 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.
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks the body's own tissues and organs. The disease can affect the skin, joints, kidneys, blood cells, brain, and other organs, leading to significant health problems and reduced quality of life. Although several treatments are available, some patients continue to have active disease despite receiving standard therapies.
Recent research has shown that B cells, a type of immune cell, play a central role in the development and persistence of SLE. CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy is an innovative treatment that uses a patient's own immune cells, genetically modified to recognize and eliminate B cells. This approach has already shown remarkable success in certain blood cancers and has recently produced encouraging results in patients with severe autoimmune diseases, including SLE.
The CLEVER-SLE study is a Phase I/II clinical trial designed to evaluate the safety and potential effectiveness of CD19-directed CAR-T cell therapy produced at Ribeirao Preto Blood Bank in patients with SLE who have not responded adequately to conventional treatments. Participants will undergo the collection of their own immune cells, which will be modified in a specialized laboratory to produce CAR-T cells. After receiving preparatory chemotherapy, participants will receive a single intravenous infusion of these CAR-T cells.
The main goal of this study is to evaluate the safety of this treatment. Researchers will also assess its effects on disease activity, symptoms, organ involvement, medication requirements, immune system markers, and the duration of clinical responses. The study aims to determine whether CD19-directed CAR-T cell therapy can provide a new treatment option for patients with refractory SLE and contribute to the development of CAR-T therapies for autoimmune diseases.
Detailed description
Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by loss of immune tolerance, production of pathogenic autoantibodies, and immune-mediated tissue injury. The disease can affect virtually any organ system, including the skin, joints, kidneys, hematologic system, cardiovascular system, and central nervous system. Despite major advances in the understanding of disease pathogenesis and the availability of immunosuppressive and biologic therapies, many patients continue to experience persistent disease activity, recurrent flares, progressive organ damage, reduced quality of life, and increased mortality.
B lymphocytes play a central role in the pathogenesis of SLE. Beyond their ability to differentiate into antibody-producing plasma cells, B cells contribute to disease development through antigen presentation, cytokine production, and maintenance of autoreactive immune responses. The persistence of autoreactive B-cell populations is believed to be a key driver of chronic disease activity and treatment resistance.
Several therapeutic strategies targeting B cells have been developed for SLE, including anti-CD20 monoclonal antibodies and inhibitors of B-cell survival pathways. Although these approaches have improved outcomes for many patients, a substantial proportion of individuals fail to achieve sustained remission. One potential limitation of antibody-based therapies is their inability to completely eliminate autoreactive B-cell populations residing within inflamed tissues and specialized immune niches. In contrast, CD19-directed CAR-T cells are living immune effectors capable of expanding in vivo, trafficking to affected tissues, and mediating deep depletion of B cells not only in the peripheral blood but also within sites of ongoing autoimmune inflammation. This broader and more profound tissue-level B-cell depletion may contribute to more durable disease control and potentially restore immune tolerance. In addition, existing therapies often require continuous administration and may be associated with cumulative toxicities, incomplete disease control, or relapse after treatment discontinuation.
CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy represents a novel therapeutic strategy that enables a patient's own T lymphocytes to recognize and eliminate CD19-expressing B cells. This approach has demonstrated unprecedented efficacy in B-cell malignancies and has transformed the treatment landscape of several hematologic cancers. More recently, emerging clinical evidence has suggested that deep B-cell depletion induced by CD19-directed CAR-T cells may also be capable of resetting abnormal immune responses in autoimmune diseases.
Early clinical experiences in patients with severe refractory autoimmune diseases, including systemic lupus erythematosus, have reported rapid and profound reductions in disease activity, sustained clinical remissions, normalization of serological markers, and significant reductions in the need for immunosuppressive medications. These findings have generated considerable interest in the potential application of CAR-T cell therapy beyond oncology and have established a strong scientific rationale for further investigation in autoimmune disorders.
The CAR-T product evaluated in this study consists of autologous T lymphocytes genetically modified to express a chimeric antigen receptor directed against CD19. The product is manufactured at the Ribeirão Preto Blood Center (Hemocentro de Ribeirão Preto), one of the leading academic cell therapy centers in Brazil. This manufacturing platform has previously demonstrated feasibility, safety, and clinical activity in patients with hematologic malignancies and serves as the foundation for the present investigation.
The CLEVER-SLE study was developed to evaluate the use of CD19-directed CAR-T cell therapy manufactured at the Ribeirão Preto Blood Center in patients with refractory systemic lupus erythematosus. The study seeks to expand current knowledge regarding the safety profile and therapeutic potential of CAR-T cells in autoimmune diseases while generating clinical evidence to support the development of advanced cellular therapies for patients with severe disease who have limited treatment options.
By investigating a strategy capable of directly targeting the cellular drivers of autoimmunity, this study aims to contribute to the development of transformative therapies that may achieve sustained disease control and improve long-term outcomes for patients with refractory SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous CD19-Directed CAR-T Cells | Experimental | Biological: Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood CenterParticipants with refractory systemic lupus erythematosus will undergo leukapheresis for the manufacture of autologous CD19-directed CAR-T cells, followed by lymphodepleting chemotherapy and a single intravenous infusion of the CAR-T cell product. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Adults aged 18 to 50 years, inclusive.
- Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 ACR/EULAR classification criteria.
- Active disease at screening, defined as SLEDAI-2K ≥4 and Physician Global Assessment (PGA) ≥0.5.
- Inadequate response, intolerance, or contraindication to corticosteroids and at least two of the following therapies: azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, belimumab, rituximab, or tacrolimus.
- Adequate organ function, including:
Key exclusion criteria (16 listed)
- Severe pulmonary hypertension (estimated pulmonary artery systolic pressure >50 mmHg).
- Requirement for systemic anticoagulation at screening.
- Clinically significant cardiovascular disease, including NYHA Class III/IV heart failure, myocardial infarction, unstable arrhythmias, or unstable angina within the previous 6 months.
- Active neurological disease (stroke, epilepsy, or neurodegenerative disorders) within the previous 12 months.
- History of malignancy within 2 years prior to screening, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, or stage I uterine cancer.
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 |
|---|---|---|
| Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood CenterAutologous CD19-directed chimeric antigen receptor T (CAR-T) cells developed and manufactured at the Ribeirão Preto Blood Center (Hemocentro de Ribeirão Preto, Brazil). T lymphocytes collected by leukapheresis are genetically modified ex vivo using a lentiviral vector to express a CD19-specific chimeric antigen receptor and subsequently expanded under Good Manufacturing Practice (GMP) conditions. Following standard lymphodepleting chemotherapy, participants receive a single intravenous infusion of the autologous CAR-T cell product. The therapy is intended to achieve deep and sustained depletion of CD19-positive B cells implicated in the pathogenesis of systemic lupus erythematosus. | Biological | Autologous CD19-Directed CAR-T Cells |
Primary outcome
Incidence and Severity of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Time frame: 30 days after CAR-T cell infusion
Incidence and maximum grade of CRS and ICANS following infusion of autologous CD19-directed CAR-T cells, assessed according to ASTCT consensus criteria.
15 secondary outcomes
Incidence of Grade ≥3 Cytopenias
Time frame: Up to 90 days after CAR-T cell infusion
Time to Hematologic Recovery
Time frame: Up to 12 months after CAR-T cell infusion
Incidence and Severity of Infections
Time frame: Up to 12 months after CAR-T cell infusion
Incidence of Serious Infections
Time frame: Up to 12 months after CAR-T cell infusion
Changes in Serum Immunoglobulin Levels
Time frame: Baseline, Day 30, Day 90, Day 180, and Day 360
Incidence of Other CAR-T Cell-Associated Toxicities
Time frame: Up to 12 months after CAR-T cell infusion
Deep Remission Rate
Time frame: 6 months after CAR-T cell infusion
SRI-4 Response Rate
Time frame: 6 months after CAR-T cell infusion
Lupus Low Disease Activity State (LLDAS) Achievement Rate
Time frame: 6 and 12 months after CAR-T cell infusion
DORIS Remission Rate
Time frame: 6 and 12 months after CAR-T cell infusion
Renal Response Rate
Time frame: 6 and 12 months after CAR-T cell infusion
Cutaneous Lupus Response Rate
Time frame: 6 and 12 months after CAR-T cell infusion
Articular Response Rate
Time frame: 6 and 12 months after CAR-T cell infusion
Anti-dsDNA Serologic Response
Time frame: 6 and 12 months after CAR-T cell infusion
Corticosteroid and Immunosuppressant-Free Remission
Time frame: 6 and 12 months after CAR-T cell 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 29 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.
Maria Carolina Oliveira Rodrigues, MD, PhD contact
2 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 Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood Center in people with Lupus Erythematosus, Systemic, run by University of Sao Paulo at 2 sites in Brazil.
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 13 inclusion and 16 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: opening soon, as of the sponsor's last update on 29 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 2 sites in Brazil. 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 Diego V. Clé, MD, MBA, PhD (+55 16 21019300, terapia@hemocentro.fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) (time frame: 30 days after CAR-T cell infusion). 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 29 Oct 2026.