Sle Systemic Lupus

10

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

Condition / disease
Location
Status: Recruiting

A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease

This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).

Participants needed: 80
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: CRISPR TherapeuticsUpdated: Jun 15, 2026Locations: 14
Eligibility criteria

Age ≥18 years and < 70 years of age. [+5]

Prior anti-CD19 therapy or any gene therapy/genetically modified cell therapy. [+12]

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: Not yet recruiting

First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics

The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults. This study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose. The main questions this study aims to answer are: I. What medical problems (side effects) may occur after receiving ISH0613? How does ISH0613 move through and get processed in the body? II. Does ISH0613 affect certain biological markers related to the immune system? III. Researchers will compare ISH0613 to a placebo (a look-alike substance that contains no active drug) to better understand its effects. Participants will: I. Receive a single intravenous infusion of either ISH0613 or placebo II. Stay in the clinical unit for several days for close monitoring after dosing III. Return to the clinic for follow-up visits over several weeks IV. Provide blood samples for safety checks and laboratory testing V. Be monitored for any side effects throughout the study

Participants needed: 26
Trial details
Phase: Phase 1Age: 18-45Biological sex: AllType: InterventionalSponsor: SUNHO(China)BioPharmaceutical CO., Ltd.Updated: Apr 13, 2026Locations: 1
Eligibility criteria

Healthy Chinese adult subjects, male or female, aged 18 to 45 years (inclusive); [+4]

Known allergy to the investigational product or any of its excipients, or a hist... [+22]

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 or 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 CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.

Participants needed: 20
Trial details
Phase: Early Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Nanjing Bioheng Biotech Co., Ltd.Updated: Mar 6, 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: Not yet recruiting

Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia

This clinical trial will assess the efficacy and safety of low-dose interleukin-2 (IL-2) treatment in systemic lupus erythematosus (SLE) complicated with cytomegalovirus (CMV) viremia.

Participants needed: 100
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Peking University People's HospitalUpdated: May 14, 2025Locations: 1
Eligibility criteria

Meet the American College of Rheumatology criteria for the diagnosis of SLE. [+4]

Inability to comply with IL-2 treatment regimen; [+11]

Status: Recruiting

Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease

This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease

Participants needed: 24
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Chongqing Precision Biotech Co., LtdUpdated: Sep 28, 2023Locations: 1
Eligibility criteria

≥18 years old, male or female; [+18]

Had previously received CAR T cell therapy; [+9]

Status: Recruiting

National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

SLE disease in Saudi Arabia is yet not well defined especially in a population with high consanguinity and high inbreeding coefficient . Up until now, there has been no prospective cohort study for SLE patients in Saudi Arabia. As a result, current published literature is focused on retrospective chart reviews which are subjected to many forms of bias. so the investigator proposed this prospective registry which will follow open cohort study design aiming to provide better understanding of disease presentation, course and outcomes especially if complemented by detailed immunological, molecular, genetic and microbiome data.

Participants needed: 1,000
Trial details
Age: 19+Biological sex: AllType: ObservationalSponsor: King Saud UniversityUpdated: Sep 1, 2021Locations: 1
Eligibility criteria

Adult patients defined as age greater than 18 years old. [+2]

Patients who don't fulfil classification criteria mentioned above.