Clinical trials: Phase 1
Shigellosis
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old…
- Trial name
- NCT04056117
- Testing
- Shigella 4V, MenACWY, Rabies
- Where
- 2 sites in Kenya
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Acute Kidney Injury, HIE
Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
Acute kidney injury is a significant complication for infants who experience hypoxic ischemic encephalopathy, being associated with increased rates of death and prolonged hospitalization.
- Trial name
- TheoPHyLNNe (NCT05853601)
- Testing
- Single Dose Theophylline, Repeat Dose Theophylline
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Medical College of Wisconsin
Severe Aplastic Anemia (SAA), Severe Aplastic Anemia, Refractory
Phase I Clinical Study of Haplo-HSCT Combined With Hypoxic 3D-Cultured Umbilical Cord MSC for the Treatment of SAA
Efficacy and Safety of Sequential Infusion of Hypoxic 3D-Cultured Umbilical Cord Mesenchymal Stem Cells in Haploidentical Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia: A Multicenter, Randomized, Phase 1 Trial
- Conditions
- Severe Aplastic Anemia (SAA), Severe Aplastic Anemia, Refractory, Severe Aplastic Anemia
- Trial name
- NCT07299123
- Testing
- 3D hypoxia-preconditioned UC-MSC group, 2D UC-MSC group
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Chinese PLA General Hospital
Hematologic Malignancy, Haplo-identical HCT
CD45RA-depleted DLI for the Treatment of Refractory/Persistent Viral Infections After Haploidentical Transplantation
The goal of this clinical trial is to learn whether giving patients special donor immune cells (called "CD45RA Depleted DLI") can help treat viral infections that have not improved with standard antiviral drugs.
- Trial name
- CD45RADLITx (NCT07662369)
- Testing
- CD45RA depleted donor lymphocyte infusion (DLI)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Ruijin Hospital
DHDDS-Congenital Disorder of Glycosylation, DHDDS-CDG
Assessing the Safety and Tolerability of NMN in DHDDS-CDG
The primary objective of this study is to evaluate the safety and tolerability of the dietary supplement, nicotinamide mononucleotide (NMN), in individuals with dehydrodolichol diphosphate synthase congenital disorder of…
- Conditions
- DHDDS-Congenital Disorder of Glycosylation, DHDDS-CDG, Congenital Disorder of Glycosylation
- Trial name
- NCT07572825
- Testing
- Nicotinamide Mononucleotide (NMN) Nucleosidase
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Eva Morava-Kozicz
Schizophrenia, Mania
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
- Trial name
- NCT00102479
- Testing
- Aripiprazole
- Volunteers
- 21 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Intraventricular Hemorrhage of Prematurity
Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage
Very preterm infants are prone to numerous medical complications with lifelong impact. Amongst the most serious neurologically are white matter injury (WMI), intraventricular hemorrhage (IVH) and the subsequent progression to…
- Trial name
- SCEMPI (NCT05617833)
- Testing
- MLT+EPO
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Johns Hopkins University
Cerebral Adrenoleukodystrophy
MT2022-01: MSCs for ALD
This is a single-institution study to evaluate the use of intravenously administered allogeneic, 3rd party mesenchymal stem cells (IV-MSC) in patients with active, cerebral adrenoleukodystrophy (CALD), as a bridge to…
- Trial name
- NCT06030648
- Testing
- Mesenchymal stem cells (IV-MSC)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Leukemia, Mantle Cell Lymphoma
RAD001 in Relapsed or Refractory AML, ALL, CML in Blastic-Phase, Agnogenic Myeloid Metaplasia, CLL, T-Cell Leukemia, or Mantle Cell Lymphoma
The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis.
- Conditions
- Leukemia, Mantle Cell Lymphoma, Myelofibrosis
- Trial name
- NCT00081874
- Testing
- RAD001
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- M.D. Anderson Cancer Center
Recurrent Medulloblastoma, Recurrent Brain Tumor, Childhood
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma.
- Conditions
- Recurrent Medulloblastoma, Recurrent Brain Tumor, Childhood, Malignant Glioma
- Trial name
- PRiME (NCT03299309)
- Testing
- PEP-CMV
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Daniel Landi
SCLC, Malignant Melanoma
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Patients with Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex(The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA…
- Conditions
- SCLC, Malignant Melanoma, Sarcoma, High Risk Neuroblastoma
- Trial name
- NCT05130255
- Testing
- GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi), GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi), GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- Y-mAbs Therapeutics
Infant, Newborn, Infant, Low Birth Weight
Delayed Cord Clamping in VLBW Infants
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT01222364
- Testing
- Standard Cord Clamping, Delayed Cord Clamping
- Where
- 4 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Conduct Disorder, Conduct Disorders in Children
Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD
Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD.
- Conditions
- Conduct Disorder, Conduct Disorders in Children, Conduct Disorders in Adolescence, Callous-Unemotional Traits
- Trial name
- NCT06301516
- Testing
- Virtual Reality, Comparative Control
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- Virginia Commonwealth University
Solid Tumors, Hepatocellular Carcinoma (HCC)
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer
In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5).
- Conditions
- Solid Tumors, Hepatocellular Carcinoma (HCC), Malignant Melanoma, Pediatric Cancer
- Trial name
- NCT06636435
- Testing
- CBA-1205 Part 1, CBA-1205 Part 2, CBA-1205 Part 3
- Where
- 5 sites in Japan
- Volunteers
- 66 people
- Sponsor
- Chiome Bioscience Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation
This research study is studying cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adult patients (18 years of age or older) with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and…
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm, Juvenile Myelomonocytic Leukemia
- Trial name
- NCT04024761
- Testing
- CIML NK, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Dana-Farber Cancer Institute
Multi-Drug Resistant Nephrotic Syndrome, CAR-T Cell Therapy
Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cell Therapy in Patients With MDR-SRNS
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-CD19 CAR-T cells in the treatment of patients with Multi-drug resistant SRNS
- Trial name
- NCT06842589
- Testing
- anti-CD19 CAR-T cells
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Perinatal Arterial Ischemic Stroke
Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal Arterial Ischemic Stroke
Autologous human umbilical cord blood (hUCB) stored at Cord Blood Registry will be given to children who have suffered from a Perinatal Arterial Ischemic Stroke.
- Trial name
- NCT02460484
- Testing
- Autologous Cord Blood Infusion
- Where
- United States
- Sponsor
- James Baumgartner, MD
Duchenne Muscular Dystrophy
NS-050/NCNP-03 in Boys With DMD (Meteor50)
This is a Phase 1/2 study of Multiple-Ascending Dose (MAD) levels for 12 weeks of treatment followed by 24 weeks of open-label treatment with a selected dose of NS-050/NCNP-03 administered once weekly to ambulant boys with DMD…
- Trial name
- NCT06053814
- Testing
- NS-050/NCNP-03
- Where
- 19 sites in United States, Canada and 3 more
- Volunteers
- 20 people
- Sponsor
- NS Pharma, Inc.
Fanconi Anemia, Anemia, Hypoplastic, Congenital
Prenatal Transplantation for Fetuses With Fanconi Anemia
The investigators aim to evaluate the safety and efficacy of in utero hematopoietic stem cell transplantation (IUHSCT) for the treatment of fetuses diagnosed with Fanconi anemia (FA) during pregnancy.
- Conditions
- Fanconi Anemia, Anemia, Hypoplastic, Congenital, Congenital Bone Marrow Failure Syndromes, Bone Marrow Failure Disorders
- Trial name
- NCT07408583
- Testing
- IUHSCT for FA-affected fetuses
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Agnieszka Czechowicz
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