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Systemic Lupus Erythematosus (SLE) Clinical Trials

24 recruiting trials for Systemic Lupus Erythematosus (SLE). Eligibility criteria explained in plain English.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.
24
Total Trials
24
Recruiting Now
1
Phase 3 Trials
10
Sponsors

Recruiting Trials

Clinical trial data sourced from the ClinicalTrials.gov registry, maintained by the National Library of Medicine. Always consult your doctor before considering any clinical trial.

RECRUITINGPhase 1NCT07085676

Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases

A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART...

Sponsor: Polina StepenskyEnrolling: 1201 location
RECRUITINGEarly Phase 1NCT06888960

Safety Study of CC312 in Autoimmune Disease Patients

This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult...

Sponsor: CytoCares IncEnrolling: 181 location
RECRUITINGPhase 1NCT07413341

A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases

This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles...

Sponsor: TherornaEnrolling: 121 location
RECRUITINGPhase 1NCT07123519

A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases

This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and...

Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.Enrolling: 181 location
RECRUITINGPhase 2NCT07340463

The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis...

1. Study Design This is a single-center, prospective, randomized, controlled, exploratory clinical trial. The study is designed to evaluate and compare the efficacy and safety of...

Sponsor: Nanjing University School of MedicineEnrolling: 501 location
RECRUITINGPhase 1NCT07104721

A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases

This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and...

Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.Enrolling: 181 location
RECRUITINGPhase 2NCT05688696

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus

This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are...

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.Enrolling: 18620 locations
RECRUITINGPhase 1 / Phase 2NCT07041801

Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells

This study will investigate the safety and efficacy of allogeneic umbilical cord-derived stem cell therapy in treating patients with moderate to severe systemic lupus...

Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.Enrolling: 581 location
RECRUITINGPhase 3NCT07332481

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of...

Sponsor: EMD Serono Research & Development Institute, Inc.Enrolling: 2023 locations
RECRUITINGEarly Phase 1NCT07339332

A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection...

This study is a single arm, open, exploratory dose escalation clinical study to evaluate the safety, efficacy, and cellular metabolic dynamics of ct1195e cells in patients with...

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyEnrolling: 121 location
RECRUITINGPhase 1 / Phase 2NCT07010835

Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with...

Sponsor: Excyte Biopharma LtdEnrolling: 1891 location
RECRUITINGEarly Phase 1NCT06946485

Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus

This investigator-initiated trial aims to evaluate the safety and efficacy of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolEnrolling: 151 location
RECRUITINGEarly Phase 1NCT07174843

An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases

This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T...

Sponsor: Shanghai Cell Therapy Group Co.,LtdEnrolling: 201 location
RECRUITINGPhase 1 / Phase 2NCT06585514

Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus

The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus (SLE).

Sponsor: Beijing GoBroad HospitalEnrolling: 181 location
RECRUITINGPhase 4NCT06875960

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or...

The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous...

Sponsor: Bristol-Myers SquibbEnrolling: 354 locations
RECRUITINGPhase 1 / Phase 2NCT06839976

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...

Sponsor: Children's Hospital of PhiladelphiaEnrolling: 241 location
RECRUITINGPhase 1 / Phase 2NCT06625671

A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE Participants

A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus

Sponsor: DualityBio Inc.Enrolling: 1484 locations
RECRUITINGPhase 1NCT06737380

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...

Sponsor: LiveKidney.BioEnrolling: 101 location
RECRUITINGPhase 1NCT06308978

A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product...

Sponsor: Fate TherapeuticsEnrolling: 24418 locations
RECRUITINGPhase 4NCT07087912

Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases

The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in...

Sponsor: University of Sao Paulo General HospitalEnrolling: 4772 locations
RECRUITINGPhase 1NCT06980597

A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases

This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed/refractory autoimmune diseases.

Sponsor: Beijing GoBroad HospitalEnrolling: 442 locations
RECRUITINGPhase 1NCT06249438

A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients...

Sponsor: RenJi HospitalEnrolling: 301 location
RECRUITINGEarly Phase 1NCT07490041

Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of...

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA CAR-NK cell injection in patients with refractory pediatric rheumatic...

Sponsor: The Children's Hospital of Zhejiang University School of MedicineEnrolling: 361 location
RECRUITINGPhase 1NCT07236801

Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases

This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and...

Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.Enrolling: 182 locations

Frequently Asked Questions

There are currently 24 clinical trials for Systemic Lupus Erythematosus (SLE), with 24 actively recruiting participants. These include trials across all phases from early-stage Phase 1 to late-stage Phase 3.

To join a clinical trial for Systemic Lupus Erythematosus (SLE), review the eligibility criteria on the trial detail pages, then talk to your doctor about whether a trial is right for you. Your doctor can help you evaluate the potential benefits and risks.

Phase 3 trials are large-scale studies that test whether a treatment is effective and monitor side effects. There are 1 Phase 3 trials for Systemic Lupus Erythematosus (SLE), representing treatments closest to potential FDA approval.

Clinical trials follow strict safety protocols overseen by Institutional Review Boards (IRBs) and the FDA. Participants are monitored closely and can withdraw at any time. Always discuss risks and benefits with your healthcare provider before enrolling.

Sources: ClinicalTrials.gov, FDA
Last updated:

Trial data sourced from the ClinicalTrials.gov API. This site does not provide medical advice, always talk to your doctor about clinical trial participation.

The this entity record above pulls directly from the NIH ClinicalTrials.gov registry. What follows is the per-entity context — how this entity sits in the broader U.S. clinical trials and research registries distribution and which underlying factors drive the headline numbers.

Every number on this page links back to the NIH ClinicalTrials.gov registry; the methodology page describes the inputs, refresh cadence, and known limitations of the underlying data product.

Practical use of this page is in combination with the comparison and ranking pages elsewhere on the site, which surface the same data for this entity’s peers within active and historical clinical trials. A single-entity reading without peer context can be misleading when an entity is an outlier on one axis but typical on another.