Clinical trials: Idiopathic Inflammatory Myopathies(IIM), open to volunteers
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Dry Syndrome, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06970951
- Testing
- UTAA91 injection
- Where
- China
- Volunteers
- 15 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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
Dermatomyositis, Polymyositis
Adult and Juvenile Myositis
This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them.
- Conditions
- Dermatomyositis, Polymyositis, Inclusion Body Myositis
- Trial name
- NCT00017914
- Where
- 4 sites in United States
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
- Conditions
- SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies, ANCA Associated Vasculitis (AAV)
- Trial name
- NCT07315087
- Testing
- QT-019C
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP)
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 (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in…
- Conditions
- Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP), Systemic Lupus Erythematosus(SLE)
- Trial name
- NCT07174843
- Testing
- CD19/CD22/BCMA CAR-T cells(BZE2204)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, Rheumatoid Arthritis
- Trial name
- NCT06733935
- Testing
- NKX019, Fludarabine, Cyclophosphamide
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 240 people
- Sponsor
- Nkarta, Inc.
Idiopathic Inflammatory Myositis (IIM), DERMATOMYOSITIS OR POLYMYOSITIS
Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM)
The goal of this clinical trial is to learn about how an umbilical cord lining-derived stem cell (ULSC) product performs when treating Dermatomyositis/Polymyositis (DM/PM), also known as idiopathic inflammatory myopathy (IIM) in…
- Trial name
- IIMPACT (NCT07160205)
- Testing
- ULSC (1.5 x 10^8 cells/dose)
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Restem, LLC.
Pericarditis, Tako-TSUBO Cardiomyopathy
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with…
- Conditions
- Pericarditis, Tako-TSUBO Cardiomyopathy, Myocarditis, Inflammatory Cardiomyopathies
- Trial name
- INFLAME-BANK (NCT07737470)
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Idiopathic Inflammatory Myopathies
Optimizing Treatment on Idiopathic Inflammatory Myopathies
As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset.
- Trial name
- NCT03092180
- Testing
- Intravenous Infusion
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- University of Sao Paulo
Dermatomyositis, Polymyositis
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis [DM] or polymyositis [PM]).
- Trial name
- NCT06698796
- Testing
- Dazukibart
- Where
- 26 sites in United States, Argentina and 10 more
- Volunteers
- 211 people
- Sponsor
- Pfizer
Systemic Lupus Erythematosus, Sjögren's Disease
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07873931
- Testing
- BMS-986553
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
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 dose that may be administered safely to patients…
- Conditions
- Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07085676
- Testing
- HBI0101 CART
- Where
- Israel
- Volunteers
- 120 people
- Sponsor
- Polina Stepensky
Idiopathic Inflammatory Myopathy (IIM)
GC012F Injection in Refractory Idiopathic Inflammatory Myopathy
This is a single-arm, open-label, early exploratory clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with refractory idiopathic inflammatory myopathy and to assess the pharmacokinetic and…
- Trial name
- NCT07086404
- Testing
- GC012F Injection infusion
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Daishi Tian
Polymyositis, Dermatomyositis
A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with…
- Trial name
- JASMINE (NCT06455449)
- Testing
- Anifrolumab (blinded), Anifrolumab (unblinded, open label)
- Where
- 237 sites in United States, Argentina and 27 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
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
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases
This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced…
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc)
- Trial name
- CELL-ATTACK 1 (NCT07544225)
- Testing
- anti-CD19 CAR-T cells
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Refractory Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathies (IIMs)
AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.
A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically…
- Conditions
- Refractory Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathies (IIMs), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA
- Trial name
- NCT06991114
- Testing
- Allogeneic NK Cells
- Where
- 52 sites in United States, Brazil and 9 more
- Volunteers
- 90 people
- Sponsor
- Artiva Biotherapeutics, Inc.
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
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 (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
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
Autoimmune Diseases, SLE - Systemic Lupus Erythematosus
RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases
This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19/BCMA dual-targeting chimeric antigen receptor T-cell…
- Conditions
- Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies
- Trial name
- NCT07674147
- Testing
- RD06-05 CART Cell Infusion
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine