Clinical trials: B-cell Mediated Autoimmune Disorders
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.
Autoimmune Diseases, Systemic Lupus Erthematosus (SLE)
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erthematosus (SLE), Multi-Drug Resistant Nephrotic Syndrome, IgA Nephropathy (IgAN)
- Trial name
- NCT07305116
- Testing
- UCAR T-cell
- Where
- China
- Volunteers
- 15 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Autoimmune Hepatitis
ADCC Mediated B-Cell dEpletion and BAFF-R Blockade
VAY736 dose testing; VAY736 efficacy and safety testing.
- Trial name
- AMBER (NCT03217422)
- Testing
- VAY736
- Where
- 28 sites in United States, Argentina and 8 more
- Volunteers
- 68 people
- Sponsor
- Novartis Pharmaceuticals
B-cell Mediated Autoimmune Disorders
Long-term Follow-up (LTFU) of Participants Who Received Azer-Cel
The main objective of this study is to collect data on the long-term safety of azer-cel, primarily through the capture of clinical events of interest (CEI) for up to 15 years following participation in TG-Azercel -101 study.
- Trial name
- NCT07577583
- Testing
- No Intervention
- Volunteers
- 32 people
- Sponsor
- TG Therapeutics, Inc.
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
Relapsed/Refractory B Cell-Mediated Autoimmune Diseases
Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases
This Phase 1, open-label study evaluates the safety, tolerability, and preliminary efficacy of RXIM002, a CD19-targeting circular RNA-mediated in-vivo CAR T-cell therapy, in adults with severe, relapsed, or refractory B…
- Trial name
- RXIM002 (NCT07322718)
- Testing
- RXIM002 product
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Ruijin Hospital
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
IgG4 Related Disease, B-cell Mediated Autoimmune Disorders
Exploratory Study of Anti-BCMA-CD19 CAR-T Cell Therapy in Relapsed or Refractory IgG4-Related Disease
The goal of this clinical trial is to test the safety and potential benefit of a new immune cell therapy called anti-BCMA-CD19 CAR-T cells in adults (18-75 years) with IgG4-related disease (IgG4-RD) that has come back or not…
- Trial name
- BC19IGG4 (NCT07148791)
- Testing
- Anti-BCMA-CD19 CAR-T cells
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Chinese PLA General Hospital
Systemic Lupus Erythematosus (SLE), Immune-mediated Necrotizing Myopathy (IMNM)
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 with autoimmune diseases refractory to standard…
- Conditions
- Systemic Lupus Erythematosus (SLE), Immune-mediated Necrotizing Myopathy (IMNM), Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS)
- Trial name
- CAR-AID (NCT06249438)
- Testing
- CD20/BCMA-directed CAR-T cells
- Where
- China
- Volunteers
- 30 people
- Sponsor
- RenJi Hospital
Multiple Sclerosis (MS), Myasthenia Gravis (MG)
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard…
- Conditions
- Multiple Sclerosis (MS), Myasthenia Gravis (MG), Neuromyelitis Optica Spectrum Disorder, Systemic Lupus Erythematosus
- Trial name
- NCT07676266
- Testing
- CD20/BCMA-directed CAR-T cells Autologous 2nd generation
- Where
- China
- Volunteers
- 18 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Systemic Lupus Erythematosus, Systemic Sclerosis
CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease
The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen…
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, Dermatomyositis, Polymyositis
- Trial name
- CASTLE (NCT06347718)
- Testing
- anti-CD19 CAR T cell therapy
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Miltenyi Biomedicine GmbH
Systemic Lupus Erythematosus, Autoimmune Hemolytic Anemia (AIHA)
Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of Arnovie101, an mRNA-LNP-Based In Vivo CAR-T Therapy, for the Treatment of B Cell-Mediated Autoimmune Diseases (SLE and AIHA)
This is an open lable and single arm study designed to evaluate the safety, PK and PD of Arnovie101 in B cell-mediated Autoimmune Disease
- Trial name
- NCT07629596
- Testing
- Arnovie101 Infusion Intravenous
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Circunited BioPharma (Shenzhen) Co., Ltd.
Type 1 Diabetes Mellitus, Multiple Sclerosis
T and B Cell Responses in Autoimmune Diseases
The study aims to establish whether defects in immune cell function are shared across multiple autoimmune diseases and whether those problems match to similar genes in the cells.
- Conditions
- Type 1 Diabetes Mellitus, Multiple Sclerosis, Arthritis, Rheumatoid, Crohn's Disease
- Trial name
- SRA01 (NCT01947036)
- Where
- 6 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lupus Erythematosus, Systemic Lupus Erythematosus
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.
- Conditions
- Lupus Erythematosus, Systemic Lupus Erythematosus, SLE (Systemic Lupus), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06294236
- Testing
- SC291
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sana Biotechnology
Relapsing-Remitting Multiple Sclerosis (RRMS), Neuromyelitis Optica
Effects of Ozanimod on Immune-mediated Mechanisms of Neurodegeneration in Multiple Sclerosis - a Preclinical Study
This is a prospective non interventional study including patients with Relapsing-Remitting Multiple Sclerosis (RRMS) or with Neuromyelitis Optica Spectrum Disorders (NMOSD) and healthy subjects, who are enrolled within the…
- Conditions
- Relapsing-Remitting Multiple Sclerosis (RRMS), Neuromyelitis Optica, Healthy
- Trial name
- NCT05245344
- Testing
- Peripheral blood withdrawal
- Where
- 3 sites in Italy
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Neuromed IRCCS
B-cell Mediated Autoimmune Disorders
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
- Trial name
- NCT06680037
- Testing
- Azercabtagene zapreleucel (azer-cel)
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- TG Therapeutics, Inc.
Autoimmune Diseases, Systemic Lupus Erthematosus
Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease
this is an investigator-initiated trial aimed at evaluating the efficacy and safety of anti-CD19/BCMA CAR-NK Cells in Patients With B cell mediated autoimmune disease.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erthematosus, Multi-Drug Resistant Nephrotic Syndrome, IgAN - IgA Nephropathy
- Trial name
- NCT06792799
- Testing
- anti-CD19/BCMA CAR NK cells (KN5601)
- Where
- China
- Volunteers
- 36 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine