Clinical trials: IIM
Relapsed/Refractory Autoimmune Diseases
Early Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Effectiveness of STR-P005
This is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in participants with relapsed/refractory autoimmune diseases.
- Trial name
- NCT07605637
- Testing
- STR-P005 dose group
- Volunteers
- 18 people
- Sponsor
- Beijing GoBroad Hospital
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathies(IIM)
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
- Trial name
- NCT07331272
- Testing
- LUCAR-G79D T cells
- Where
- 5 sites in China
- Volunteers
- 38 people
- Sponsor
- Nanjing Legend Biotech Co.
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
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.
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), ANCA Associated Vasculitis (AAV)
- Trial name
- NCT06980597
- Testing
- OL-108
- Where
- 2 sites in China
- Volunteers
- 44 people
- Sponsor
- Beijing GoBroad Hospital
Type 1 Diabetes, Type 2 Diabetes
A Study of an Insulin Management System in Participants With Type 1 or Type 2 Diabetes
The purpose of this study is to investigate the user experience of an integrated insulin management system (IIM) in participants with type 1 or type 2 diabetes.
- Trial name
- NCT04484779
- Testing
- IIM System, Insulin Lispro and/or Insulin Glargine
- Where
- 5 sites in United States
- Volunteers
- 67 people
- Sponsor
- Eli Lilly and Company
MYOPATHY
Stem Cell Transplantation in Idiopathic Inflammatory Myopathy Diseases
Myositis is a disease, believed to be due to immune cells, cells which normally protect the body, but are now attacking the muscles and other organ systems within body.
- Trial name
- NCT00278564
- Testing
- Hematopoietic stem cell transplantation, Cyclophosphamide, Mesna
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Northwestern University
Recurrent or Refractory Systemic Lupus Erythematosus, Recurrent or Refractory IgG4 Related Diseases
the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases
This study is designed as a single arm, open label, single center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetic or pharmacodynamic characteristics of the investigational drug V001-BCMA in…
- Conditions
- Recurrent or Refractory Systemic Lupus Erythematosus, Recurrent or Refractory IgG4 Related Diseases, Recurrent or Refractory Systemic Sclerosis, Recurrent or Refractory Idiopathic Inflammatory Myopathy
- Trial name
- NCT07339540
- Testing
- V001-BCMA
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Tongji Hospital
Idiopathic Inflammatory Myopathies, Inflammatory Myopathies
A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have failed prior therapies.
- Trial name
- NCT06524687
- Testing
- Imvotamab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- IGM Biosciences, Inc.
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Inflammatory Myositis, Idiopathic Inflammatory Myositis
Clinical Database and Biobank of Patients With Inflammatory Myopathies: the MASC Project (Myositis, DNA, Serum, Cells) (MASC)
Myositis are rare diseases for which the development of a cohort associated with a bank of biological samples (biobank) will allow for the conduct of researches to better delineate the underlying pathophysiology and find cures.
- Conditions
- Inflammatory Myositis, Idiopathic Inflammatory Myositis, Drug-induced Inflammatory Myositis
- Trial name
- MASC (NCT04637672)
- Where
- France
- Volunteers
- 1,273 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Idiopathic Inflammatory Myopathies
Phase 2 Study of Rapcabtagene Autoleucel in Myositis
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)
- Trial name
- NCT06665256
- Testing
- Rapcabtagene autoleucel, Active Comparator Option
- Where
- 68 sites in United States, Australia and 13 more
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
SLE, Sclerosis
A Study of RD06-04 in Patients With Active Autoimmune Diseases
This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by…
- Conditions
- SLE, Sclerosis, ANCA Associated Vasculitis, IIM
- Trial name
- NCT06548620
- Testing
- RD06-04 cell infusion
- Where
- China
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Relapsed/Refractory Autoimmune Diseases
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Trial name
- NCT06866080
- Testing
- LCAR-AIO T cells
- Where
- 4 sites in China
- Sponsor
- Nanjing Legend Biotech Co.
Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA)
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 patients aged 12 to 59 years with autoimmune…
- Conditions
- Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Systemic Lupus Erythematosus (SLE), Juvenile Systemic Lupus Erythematosus
- Trial name
- BTNDV-ARD (NCT07087912)
- Testing
- Dengue 1,2,3,4 (attenuated) vaccine
- Where
- 2 sites in Brazil
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Muscular Dystrophies, Congenital Myopathy
Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders
The aims of the current study are as follow: i) Evaluate the safety, usability, and acute efficiency of a powered knee-hip dermoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland) in patients with neuromuscular disorders, ii)…
- Conditions
- Muscular Dystrophies, Congenital Myopathy, Idiopathic Inflammatory Myopathies, Mitochondrial Myopathies
- Trial name
- Exo-NMD1 (NCT05200702)
- Testing
- Knee-hip Powered Soft Exoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland)
- Where
- France
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Institut de Myologie, France
Inflammatory Myopathy
Low-dose Interleukin-2 in Combination With Standard Therapy on Idiopathic Inflammatory Myopathy
This study aims to explore the clinical and immunological efficacy of low-dose Interleukin-2 (IL-2) and cyclosporin a (CSA) on idiopathic inflammatory myopathy (IIM)
- Trial name
- NCT04237987
- Testing
- Interleukin-2, ciclosporin and corticosteroid
- Volunteers
- 20 people
- Sponsor
- Peking University People's Hospital
IBM, IIM
MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)
Myositis diseases are each rare diseases. As in other rare diseases, people living with myositis diseases face physical and psychosocial challenges that may not be recognized in current research priorities.
- Conditions
- IBM, IIM, Myositis, Inflammatory Myopathy
- Trial name
- MIHRA-PRISMS (NCT07374107)
- Testing
- No intervention - qualitative and mixed methods investigations
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Myositis International Health & Research Collaborative Alliance Foundation
Polymyositis, Dermatomyositis
Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.
This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM) who completed the double-blind treatment period of Study KZR-616-003, up to…
- Trial name
- NCT04628936
- Testing
- KZR-616
- Where
- 10 sites in United States, Czechia
- Volunteers
- 18 people
- Sponsor
- Kezar Life Sciences, Inc.
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of KITE-363 in Participants With Refractory Autoimmune Diseases
This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathy
- Trial name
- NCT07038447
- Testing
- KITE-363, Fludarabine, Cyclophosphamide
- Where
- 10 sites in United States, Australia and 2 more
- Volunteers
- 52 people
- Sponsor
- Kite, A Gilead Company
Systemic Lupus Erythematosus, Lupus Nephritis
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Autoimmune Diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- BAH242 (NCT06350110)
- Testing
- CD19- BCMA CAR-T cells
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Essen Biotech
SLE - Systemic Lupus Erythematosus, Systemic Sclerosis
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune…
- Conditions
- SLE - Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07596680
- Testing
- RD06-05 CAR-T Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.