Phase 1 Systemic Lupus Clinical Trials

96 recruitingPhase 1

What is a Phase 1 trial?

Phase 1 trials test a new treatment in a small group of people for the first time. The primary goal is to evaluate safety, determine a safe dosage range, and identify side effects. These studies typically enroll 20 to 80 participants.

Showing 120 of 96 trials

Recruiting
Phase 1

A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE) and Sjogren's Disease (SjD)

dry eye syndromeSystemic Lupus Erythematosus
AbbVie36 enrolled7 locationsNCT06977724
Recruiting
Phase 1

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

SLESLE (Systemic Lupus)
Cullinan Therapeutics Inc.24 enrolled17 locationsNCT06613360
Recruiting
Phase 1Phase 2

A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus

Refractory Systemic Lupus Erythematosus
Gracell Biotechnologies (Shanghai) Co., Ltd.118 enrolled2 locationsNCT06530849
Recruiting
Phase 1

A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)

Rheumatoid ArthritisSystemic Lupus Erythematosus
Merck Sharp & Dohme LLC21 enrolled9 locationsNCT07363590
Recruiting
Phase 1

Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

Malignant Solid NeoplasmHematopoietic and Lymphoid Cell NeoplasmRheumatoid Arthritis+11 more
National Cancer Institute (NCI)300 enrolled52 locationsNCT03816345
Recruiting
Phase 1

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
Hoffmann-La Roche70 enrolled24 locationsNCT05835986
Recruiting
Phase 1

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

Rheumatoid Arthritis (RA)Systemic Lupus Erythematosus (SLE)Neuromyelitis Optica Spectrum Disorder (NMOSD)+6 more
Polina Stepensky120 enrolled1 locationNCT07085676
Recruiting
Phase 1

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

Systemic Lupus Erythematosus (SLE)Systemic Sclerosis (SSc)Lupus Nephritis+2 more
Fate Therapeutics244 enrolled18 locationsNCT06308978
Recruiting
Phase 1

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

Rheumatoid ArthritisSystemic Lupus ErythematosusSystemic Sclerosis+1 more
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company270 enrolled54 locationsNCT05869955
Recruiting
Phase 1

Efficacy and Safety of HN2301 in Autoimmune Diseases(AIDs)

Rheumatoid ArthritisSclerodermaSystemic Lupus Erythematosus
Shenzhen MagicRNA Biotechnology Co., Ltd30 enrolled1 locationNCT06801119
Recruiting
Phase 1

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.

Rheumatoid ArthritisSystemic Lupus ErythematosusIdiopathic Inflammatory Myopathies
AstraZeneca72 enrolled35 locationsNCT06916806
Recruiting
Phase 1

A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants

Systemic Lupus Erythematosus
GlaxoSmithKline142 enrolled27 locationsNCT06576271
Recruiting
Phase 1

Alnuctamab for Refractory SLE (LATTE Study)

Systemic Lupus Erythematosus
Icahn School of Medicine at Mount Sinai21 enrolled1 locationNCT07219563
Recruiting
Phase 1

A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

Rheumatoid ArthritisHealthySystemic Lupus Erythematosus
Eli Lilly and Company63 enrolled7 locationsNCT07276958
Recruiting
Phase 1Phase 2

Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders

Systemic Lupus ErythematosusLupusAutoimmune Disorders+2 more
M.D. Anderson Cancer Center47 enrolled2 locationsNCT06434363
Recruiting
Phase 1

A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
Nanjing Leads Biolabs Co.,Ltd112 enrolled11 locationsNCT07323173
Recruiting
Phase 1Phase 2

Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders

Juvenile Myasthenia GravisANCA Associated Vasculitis (AAV)Juvenile Dermatomyositis+1 more
Cartesian Therapeutics50 enrolled2 locationsNCT07089121
Recruiting
Phase 1Phase 2

RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

Systemic Lupus ErythematosusLupus Nephritis
Cabaletta Bio28 enrolled23 locationsNCT06121297
Recruiting
Phase 1Phase 2

SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus

Lupus NephritisRefractory Systemic Lupus Erythematosus
Beijing Biotech24 enrolled1 locationNCT07523542
Recruiting
Phase 1

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus
Genentech, Inc.162 enrolled2 locationsNCT06984341