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BMI dependent regulation of macrophages and monocytes in pregnancy

Primary Objective: analyse the effect of maternal BMI on levels of macrophage cell and monocyte subsets in decidual tissue and maternal blood. Secondary Objective: analyse differences in the effect of maternal blood stimulation with conditioned…

An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients

The objectives of this study are to:• Assess safety and tolerability of imlifidase in combination with standard IVIg treatment in GBS subjects• Evaluate pharmacokinetics of imlifidase• Evaluate pharmacodynamics profile of imlifidase• Evaluate…

Mapping the peritoneal immune system to identify novel immunomodulatory treatment options for diseases with peritoneal involvement.

AimThe MAPS study aims to unravel the immune composition of the human peritoneal cavity and the tumor immune environment in peritoneal metastasized gastric and colorectal cancer. The overarching aim is to find new targets for immunotherapy for this…

2000 HIV Human Functional Genomics Partnership Program

Primary Objectives• Employ a systems biology approach to identify a set of candidate biomarkers (BM) in circulation and/or pathways & mechanisms that correlate with particular non-AIDS defining comorbidities (ie NASH, CVD) in HIV+…

Study to evaluate the effects of intravenously administered LPS on the bone marrow immune cell compartment in healthy male volunteers

• To investigate the (early) effects of i.v. LPS challenge model on the bone marrow and whole-blood immune compartments, by: o evaluating the immune cell subtypes present within the myelo- and lymphopoiesis in the bone marrow niche before and after…

Determination of reference values: numbers, repertoire and products of leukocytes in immunological healthy elderly

Generation of (age-dependent) reference values **of leukocytes and their subtypes and of their products, as well as analysis of (age-dependent) IG / TR repertoire. In order to be able to distinguish the age-dependent effects from effects caused by…

A Phase I-II study of virus neutralizing antibodies against SARS-CoV-2. A focus on convalescent plasma and hyperimmune anti-SARS-CoV2 immunoglobulines

Primary Objective:• To create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in ConvP.• To create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in Nanogam*plusSecondary…

A dermal inflammatory challenge study to evaluate complement activation in healthy volunteers

Primary objectives• To evaluate complement activation after topical imiquimod challenge• To evaluate complement activation after local UV-B challenge

Leukapheresis of healthy volunteer donors for T cell study and TolDC production process validations

To obtain fresh mononuclear cells from healthy volunteer donors to be used for validation of procedures for the generation of GMP-grade T cell or tolerogenic dendritic cell products for clinical application.

Post-traumatic dysfunction of the innate and adaptive immune system and its relationship with the development of infectious complications in severely injured patients (POSEIDON study)

We expect to provide evidence for our hypothesis stating that patients who develop infectious complications after trauma are characterized by a specific subset of circulating neutrophils displaying a reduced capacity to eradicate bacteria.…

A randomized, double-blind, placebo-controlled crossover study to assess the effect of 12-week fibre supplementation on mixed-meal challenge response in adults

Primary ObjectiveTo relate microbiome modulation by dietary fibre supplementation, as measured by 16S rRNA sequencing, to changes in response to a mixed-meal metabolic challenge (PhenFlex) as measured by composite biomarker score.Secondary…

A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF)

Primary: • Assessment of the safety and tolerability of PLN-74809 Secondary:• Assessment of pharmacokinetics (PK) of PLN-74809 Exploratory:• Assessment of change from baseline in forced vital capacity (FVC) • Assessment of change from baseline in…

Heavy water labeling of leukocytes in human skin and vet and additional cell populations in fat such as macrophages and adipocytes

The primary objective of this study is to quantify the dynamic properties of different leukocyte subpopulations in healthy skin and blood. Secondly, we aim to understand the relationship between leukocytes in skin and those circulating through the…

A Multicentre, Open-Label, Single Ascending Dose, Dose-Ranging, Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant Recipients.

This study has been transitioned to CTIS with ID 2024-512579-11-00 check the CTIS register for the current data. Primary:- To evaluate the short-term safety and tolerability of TX200-TR101 from the day of TX200 TR101 infusion within 28 days post…

A Phase 2 Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Narsoplimab in Paediatric Patients (28 Days to 18 Y.O.) with High Risk Haematopoietic Stem Cell Transplant Thrombotic Microangiopathy

This study has been transitioned to CTIS with ID 2023-509710-11-00 check the CTIS register for the current data. Study Objectives:The purpose of this Phase 2 study is to evaluate the safety, efficacy, pharmacokinetics (PK),pharmacodynamics (PD), and…

A randomised, double-blind, controlled trial to evaluate the effects of a nutritional product on brain integrity in preterm infants

>Primary objective:During the intervention period (from randomisation until and including Term Equivalent Age [TEA]): To investigate the effect of the test product vs. the control product given to preterm infants born at 24+0 to <30+0…

PIONEER: Psychiatric and Immune phenotyping of rare genetic neurodevelopmental syndromes

The aims of this study are:1. To describe the neuropsychiatric profiles associated with DDX3X syndrome, SETD1A syndrome, Koolen-De Vries syndrome, KBG syndrome, DYRK1A syndrome, Jansen-De Vries syndrome, Gabriele-De Vries syndrome, and Smith-Magenis…

The immune biological basis of severe fatigue after COVID-19 infection (IMMUNOFATIGUE)

To test the hypotheses that patients who show severe fatigue after COVID-19 infection exhibit an exaggerated abnormal expression of inflammatory monocyte genes (particularly of the genes involved in pyroptosis, such as IL-1 and IL-6) as compared to…

Long-Term Follow-Up of Patients who have received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in a prior clinical study.

This study has been transitioned to CTIS with ID 2024-512580-31-00 check the CTIS register for the current data. PrimaryTo evaluate the long-term safety and tolerability of TX200-TR101 up to 15 years post-TX200-TR101 infusion/baseline.SecondaryTo…

Post-COVID Complaints in children Study (POCOS)

We aim to describe the clinical characteristics and immune response in children seeking care for post-COVID complaints. Moreover, in a subset of children we evaluate the effect of the reinfection on clinical and inflammatory outcomes in children…