Clinical trials: Antibody Mediated
Stem Cell Transplant Complications
KIR Sequencing and Typing for Allograft in Nancy
The use of haploidentical donors for aHSCT has greatly increased this past decade leading to a major paradigm shift: while finding 10/10 HLA-matched donors represented the prior difficulty for decades, the current problem is…
- Trial name
- KIR-STAN (NCT04882605)
- Testing
- MHC typing, KIR typing, Assessment of KIR-based prediction scores
- Volunteers
- 156 people
- Sponsor
- Central Hospital, Nancy, France
IgA Nephropathy (IgAN), Membranous Nephropathy
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase.
- Conditions
- IgA Nephropathy (IgAN), Membranous Nephropathy, ANCA-associated Vasculitis (AAV)/ANCA-associated Glomerulonephritis (AAGN), Refractory Podocytopathy
- Trial name
- NCT07389499
- Testing
- CD19-targeted iNKT Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Grit Biotechnology
Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD)
Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
This study is an open-label, exploratory, prospective clinical trial with dose escalation(according to "3+3" design), to evaluate the safety and tolerability of QH103(Universal CD19 CAR-γδT Cell Injection)in the treatment of…
- Conditions
- Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), Autoimmune Encephalitis (AE), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Trial name
- NCT07526493
- Testing
- Universal CD19 CAR-γδT Cell Injection, Cyclophosphamide, Fludarabine
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Tongji Hospital
ABO Blood Type Incompatible Kidney Transplantation, Antibody-mediated Rejection
Diagnostic Efficacy of Molecular Diagnostic Method for AMR in ABOiKT
The purpose of this study is to determine whether the peripheral blood marker-based molecular diagnostic method developed in the previous study can differentiate and predict accommodation and antibody-mediated rejection (AMR) in…
- Trial name
- NCT04541914
- Testing
- 5-gene classification model
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- Seoul National University Hospital
Chronic Kidney Disease, Inflammation
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.
The purpose of this research study is to compare the safety and effectiveness of 2 different doses of a study drug called ziltivekimab to placebo (an inactive substance) in reducing inflammation and improving some of the bad…
- Conditions
- Chronic Kidney Disease, Inflammation, Cardiovascular Risk
- Trial name
- RESCUE-2 (NCT04626505)
- Testing
- Ziltivekimab
- Where
- Japan
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
Inflammatory Myopathy, Idiopathic, Dermatomyositis
Add-on Intravenous Immunoglobulins in Early Myositis
In patients with myositis early immunomodulation by intensive treatment ("hit-early/hit-hard" principle) may induce faster reduction of disease activity and prevent chronic disability.
- Conditions
- Inflammatory Myopathy, Idiopathic, Dermatomyositis, Antisynthetase Syndrome, Immune-Mediated Necrotizing Myopathy
- Trial name
- TIMEISMUSCLE (NCT05832034)
- Testing
- Immune Globulin Intravenous (Human)
- Where
- Netherlands
- Volunteers
- 44 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Liver Transplant Failure, Antibody-mediated Rejection
Antibodies and Liver Retransplantation
Despite reports that associate donor specific antibody (DSA) with rejection after liver transplantation, grafts are still allocated according to blood group (ABO) but not human leukocyte antigen (HLA) compatibility, possibly due…
- Trial name
- NCT03815864
- Testing
- Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation
- Volunteers
- 200 people
- Sponsor
- London Health Sciences Centre
Kidney Transplantation, Antibody-mediated Rejection
CD38 mAb Induction + Azathioprine Maintenance for Chronic Active AMR in Kidney Transplant Recipients
This multicenter, prospective, single-arm exploratory study evaluates the efficacy and safety of a novel sequential regimen for chronic active antibody-mediated rejection (caABMR) in kidney transplant recipients: single-dose CD38…
- Trial name
- CAZA (NCT07718308)
- Testing
- CD38, Azathioprine (AZA), Standard Triple Immunosuppression Maintenance
- Volunteers
- 20 people
- Sponsor
- wujianyong
Kidney Transplant
Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant
A strongly positive crossmatch has long been considered an absolute contraindication to kidney transplantation and most patients with anti-human leukocyte antigen (HLA) antibody never were able to receive a kidney transplant.
- Trial name
- NCT00670774
- Testing
- Eculizumab
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Mark Stegall
Antibody-mediated Rejection
A Pilot Trial of Clazakizumab in Late ABMR
This bi-center study (Medical University of Vienna \& Charité Berlin) is an investigator-driven pilot trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy (preliminary assessment) of…
- Trial name
- NCT03444103
- Testing
- Clazakizumab / Clazakizumab
- Where
- 2 sites in Austria, Germany
- Volunteers
- 20 people
- Sponsor
- Medical University of Vienna
Antibody Mediated Rejection After Kidney Transplantation
Peripheral and Intrarenal B Cell Study in Antibody Mediated Transplant Rejection : Phenotypic and Transcriptional Study, Study of Reactivity
Humoral rejection of kidney transplants is responsible for a large number of kidney graft losses in a context of increasing shortage.
- Trial name
- B-KiMi (NCT07134491)
- Testing
- Piece of kidney removal, Stool collection, Blood collection
- Where
- 2 sites in France
- Volunteers
- 45 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Graft Rejection
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
- Trial name
- NCT01147302
- Testing
- C1 Esterase Inhibitor (Human)
- Where
- 5 sites in United States, Germany
- Volunteers
- 18 people
- Sponsor
- Shire
Kidney Transplant Rejection
Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients
The aim of the present study is to evaluate the superiority of photopheresis in combination with the standard immunosuppression vs standard immunosuppression alone for the prevention of acute rejection in highly sensitized kidney…
- Trial name
- NCT04414735
- Testing
- Extracorporeal Photopheresis
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
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
- 12 sites in United States
- Volunteers
- 240 people
- Sponsor
- Nkarta, Inc.
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
Kidney Transplantation
Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection
Organ transplantation offers the only hope for a normal life for patients with end-stage renal disease on dialysis (ESRD). For the highly-sensitized patient, patients with antibodies to human leukocyte antigens (HLA)…
- Trial name
- NCT01134510
- Testing
- C1 Esterase Inhibitor
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stanley Jordan, MD
Kidney Transplant, Rejection of Renal Transplant
Development and Validation of HistoMX, a Gene-Expression Platform for Molecular Interpretation of Kidney Allograft Biopsies
This retrospective multicentre observational study developed and validated HistoMX, an automated gene-expression-based platform for multidimensional molecular interpretation of kidney allograft biopsies.
- Conditions
- Kidney Transplant, Rejection of Renal Transplant, Antibody Mediated Rejection, BK Virus Nephropathy
- Trial name
- HistoMX (NCT07700563)
- Volunteers
- 2,410 people
- Sponsor
- Paris Translational Research Center for Organ Transplantation
Antibody-mediated Rejection
Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.
- Trial name
- IMAGINE (NCT03744910)
- Testing
- Clazakizumab, Physiologic saline solution
- Where
- 142 sites in United States, Australia and 13 more
- Volunteers
- 194 people
- Sponsor
- CSL Behring
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.
Rejection Chronic Renal, Kidney Transplant Rejection
Longitudinal Changes in Donor-Derived Cell-Free DNA With Tocilizumab Treatment for Chronic Antibody-Mediated Rejection
Our group recently reported that tocilizumab, a humanized monoclonal antibody against the IL-6 receptor, may be effective when administered monthly to patients with chronic antibody-mediated rejection (ABMR).
- Trial name
- NCT03859388
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cedars-Sinai Medical Center