Clinical trials: B-cell Mediated Autoimmune Disorders, open to volunteers
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, 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.
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
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
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
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
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
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
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
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
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- TG Therapeutics, Inc.
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.