SLE

14

Review clinical trials related to SLE. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus

This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE). Phase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.

Participants needed: 24
Trial details
Phase: Phase 1, Phase 2Age: 12-29Biological sex: AllType: InterventionalSponsor: Children's Hospital of PhiladelphiaUpdated: Jun 15, 2026Locations: 1
Eligibility criteria

Signed informed consent form must be obtained prior to any study procedure. Labs... [+11]

Active, untreated infections [+15]

Status: Recruiting

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).

Participants needed: 24
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Cullinan Therapeutics Inc.Updated: Jun 5, 2026Locations: 20
Eligibility criteria

Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR... [+13]

Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's s... [+14]

Status: Recruiting

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus

The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE). Another goal is to learn about the safety of VENT-03 and how it is processed by the body. The main questions it aims to answer are: * Does VENT-03 affect the activity and severity of CLE? * What side effects do participants have when taking VENT-03? Researchers will compare VENT-03 to a placebo (a look-alike substance that contains no drug) to see if VENT-03 works to treat patients with CLE. Participants will: * Take VENT-03 or a placebo for 4 weeks, then all participants will switch to VENT-03 for another 8 weeks; * Visit the clinic once a month for checkups and tests.

Participants needed: 24
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Ventus Therapeutics U.S., Inc.Updated: Apr 6, 2026Locations: 27
Eligibility criteria

CLASI-A score ≥8; [+4]

Meet protocol-specified infection or lab criteria; any other laboratory test res... [+11]

Status: Recruiting

Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases

This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG

Participants needed: 18
Trial details
Phase: Early Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Nanjing Bioheng Biotech Co., Ltd.Updated: Feb 2, 2026Locations: 1
Eligibility criteria

The subjects voluntarily participated in the study and signed the informed conse... [+21]

SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to s... [+6]

Status: Not yet recruiting

Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus

The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE). The main objectives of the study are: 1. To determine whether CRC01 infusion can improve kidney outcomes and reduce disease activity in participants with lupus nephritis. 2. To assess the safety profile, including potential risks such as cytokine release syndrome (CRS) and neurotoxicity. Study Design This is a single-arm, open-label, multi-center, Phase 1/2 study. All enrolled participants will receive CRC01 after screening and baseline assessments. Study Procedures Participants will: * Undergo eligibility screening, including blood tests, urine tests, and disease activity assessments. * Provide autologous T lymphocytes through a procedure called leukapheresis. * Receive a lymphodepleting pre-conditioning regimen (short course of chemotherapy). * Receive a single intravenous infusion of CRC01 cells. * Be hospitalized for close monitoring to detect and manage early adverse events such as CRS or neurotoxicity. * Return for scheduled follow-up assessments through Week 52 (12 months) post-infusion to evaluate safety and treatment response. Key Outcomes Researchers will measure: * Changes in proteinuria and kidney function. * Changes in disease activity scores. * Incidence and severity of adverse events.

Participants needed: 39
Trial details
Phase: Phase 1, Phase 2Age: 19+Biological sex: AllType: InterventionalSponsor: Curocell Inc.Updated: Jan 23, 2026
Eligibility criteria

Age 19 years or older, voluntarily provides written informed consent. [+10]

Current or anticipated requirement for renal dialysis during the study. [+29]

Status: Recruiting

Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus

This is an observational, monocentric, retrospective cohort study. Its primary objective is to examine maternal and foetal outcomes in pregnancies that occurred before the diagnosis of systemic lupus erythematosus (SLE) in a group of female participants who were subsequently diagnosed with the condition.

Participants needed: 50
Trial details
Age: 18-55Biological sex: FemaleType: ObservationalSponsor: University of AlgiersUpdated: Dec 31, 2025Locations: 2
Eligibility criteria

Women of childbearing age with a history of at least one pregnancy [+3]

Status: Recruiting

A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.

To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).

Participants needed: 40
Trial details
Phase: Phase 1, Phase 2Age: 18-65Biological sex: FemaleType: InterventionalSponsor: Ascentage Pharma Group Inc.Updated: Dec 16, 2025Locations: 1
Eligibility criteria

1. Diagnosis of systemic lupus erythematosus for at least 6 months. [+3]

1. Severe systemic lupus erythematosus. [+2]

Status: Recruiting

Safety and Efficacy of ONT01 in Lupus

ONT01 is a drug that is being studied for the treatment of Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) and is not approved by the FDA. The purpose of this study is to better determine whether ONT01 is safe and tolerated by people with lupus nephritis or SLE. The study also looks at how the administration of ONT01 in combination with widely used treatments given for lupus, including the medication mycophenolate mofetil and others, can improve symptoms of lupus. A total of 61 participants will be enrolled in this study.

Participants needed: 61
Trial details
Phase: Early Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hospital for Special Surgery, New YorkUpdated: Nov 20, 2025Locations: 1
Eligibility criteria

≥ 18 years old and able to provide informed consent to participate. [+6]

Any condition, including any uncontrolled disease (eg, asthma, interstitial lung... [+20]

Status: Recruiting

A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.

An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN, SSc, and IIM).

Participants needed: 84
Trial details
Phase: Early Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Nanjing Bioheng Biotech Co., Ltd.Updated: Oct 2, 2025Locations: 1
Eligibility criteria

Willing and able to provide written informed consent. [+21]

Severe active central nervous system (CNS) lupus, including psychosis, seizures,... [+11]

Status: Recruiting

UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients

The goal of this clinical trial is to evaluate the safety and effectiveness of UC-MSCs in adults with systemic lupus erythematosus (SLE). The main questions this study aims to answer are: 1. Can UC-MSCs improve kidney function and reduce SLE disease activity? 2. Are UC-MSCs safe and well-tolerated in this patient population? Participants in this study will: * Receive UC-MSCs in a single dose in addition to standard of care treatment. * Provide blood and urine samples for laboratory assessments, including biomarkers and immune profiling (e.g., cytokines, complement proteins, and autoantibodies). * Attend regular clinic visits for physical exams, disease activity scoring, and imaging tests to monitor kidney health. * Complete assessments for safety, such as monitoring for adverse events and changes in laboratory values. This study aims to provide new insights into treatment options for SLE and lupus nephritis, addressing an unmet medical need in this population.

Participants needed: 10
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: LiveKidney.BioUpdated: Sep 11, 2025Locations: 1
Eligibility criteria

Age 18-75 years at the time of screening [+7]

History of any non-systemic lupus erythematosus (non-SLE) disease that required... [+15]

Status: Not yet recruiting

Association of Serum Interleukin-33 Levels With Clinical Manifestations in Systemic Lupus Erythematosus

This is a case-control study investigating serum IL-33 levels and their association with clinical manifestations in systemic lupus erythematosus (SLE). The study compares IL-33 levels in three groups: SLE patients with lupus nephritis, SLE patients without nephritis, and healthy controls. The goal is to clarify IL-33's role as a biomarker reflecting disease activity and organ involvement, especially renal pathology.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Sep 2, 2025
Eligibility criteria

Adults aged 18 years and older. [+3]

Patients with other autoimmune diseases. Patients with chronic infections or mal...

Status: Not yet recruiting

Assessment of Blood Indices in Systemic Lupus Erythematosus

This case-control study aims to explore the relationship between specific blood indices (lymphocyte-monocyte ratio, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic immune-inflammatory index) and disease activity in patients with systemic lupus erythematosus (SLE). The study includes 70 SLE patients and 70 healthy controls, matched for age and gender, recruited from Assiut University Hospital. Disease activity is assessed using the SLEDAI-2K score, and blood indices are analyzed to determine correlations with disease activity.

Participants needed: 70
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Assiut UniversityUpdated: Mar 12, 2025Duration: 1 Month
Eligibility criteria

Patients aged 18 years or older diagnosed with SLE according to the 2019 ACR/EUL... [+1]

• Patients with other autoimmune diseases (e.g., rheumatoid arthritis, Sjögren's... [+2]

Status: Not yet recruiting

Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers

assessment of psychiatric problems in pediatric SLE and their caregivers. evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.

Participants needed: 62
Trial details
Age: 11-18Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Feb 4, 2025
Eligibility criteria

Age from 11 to 18 years [+3]

No history of psychiatric illness prior to the diagnosis of lupus. [+1]

Status: Recruiting

Argentinian Prospective Registry of Patients With Lupus

In Latin America, information about patients with systemic lupus erythematosus (SLE) is limited. Multicenter studies are needed to obtain "real world data '' and to carry out longer follow-ups. The purpose of this project is to design a cohort of Argentinian patients with SLE to describe "our real setting" and to identify possible limitations in access to specialized consultations and treatments.

Participants needed: 1,500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Sociedad Argentina de ReumatologiaUpdated: Jul 22, 2022Locations: 1
Eligibility criteria

Patients ≥ 18 years of age [+3]

Diagnosis of other systemic autoimmune diseases or overlap syndromes [+1]