Clinical trials: Phase 1
Malaria
Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1)
Background: Malaria is a disease that affects many people in Africa. It is caused by germs carried by some mosquitoes. A person bitten by an infected mosquito will get malaria.
- Trial name
- NCT05652504
- Testing
- PfSPZ Vaccine, PfSPZ Diluent, Normal Saline
- Where
- Mali
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Leukemia, Acute Myeloid Leukemia
A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
This is a single-arm pilot clinical trial evaluating dalbavancin-based prophylaxis in children and adolescents with acute myeloid leukemia or relapsed lymphoblastic leukemia receiving myelosuppressive chemotherapy.
- Conditions
- Leukemia, Acute Myeloid Leukemia, Lymphoblastic Leukemia in Children
- Trial name
- NCT06810583
- Testing
- Dalbavancin, Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- St. Jude Children's Research Hospital
Glioblastoma, High-Grade Glioma (WHO III-IV)
Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)
This is an open label, intra-patient dose escalation, to evaluate ADI-PEG 20, in combination with Temozolomide (TMZ) and radiation therapy (RT) in children, adolescents and young adult patients with newly diagnosed high grade…
- Conditions
- Glioblastoma, High-Grade Glioma (WHO III-IV), High-grade Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
- Trial name
- NCT07389278
- Testing
- ADI-PEG 20 (Arginine deiminase pegylated), Temozolomide (TMZ), Standard of Care Radiation Therapy (RT)
- Where
- United States
- Volunteers
- 97 people
- Sponsor
- Sabine Mueller, MD, PhD
Pediatric Tumor of CNS, Pediatric Tumor of Brain
A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors
This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas.
- Conditions
- Pediatric Tumor of CNS, Pediatric Tumor of Brain, Diffuse Midline Glioma, H3 K27M-Mutant, Pediatric Tumor of Brain Stem
- Trial name
- NCT06357377
- Testing
- NEO100
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neonc Technologies, Inc.
Birth Asphyxia
Finding Solutions to Thrive After Birth Asphyxia in Africa
Neonatal encephalopathy (NE) is the third leading cause of under 5-year mortality and contributes substantially to long-term neurological morbidity worldwide.
- Trial name
- SANE-Uganda (NCT05275725)
- Testing
- Sildenafil
- Where
- Uganda
- Volunteers
- 18 people
- Sponsor
- Pia Wintermark
Recurrent Childhood Malignant Solid Neoplasm, Recurrent Childhood Neuroblastoma
Testing the Addition of an Anti-Cancer Drug, Daraxonrasib, for Relapsed or Refractory Solid Tumors With RAS Mutations
This phase I/II trial tests the safety, side effects, best dose and how well giving daraxonrasib works for the treatment of pediatric patients with solid tumors with RAS mutations that has come back after a period of improvement…
- Conditions
- Recurrent Childhood Malignant Solid Neoplasm, Recurrent Childhood Neuroblastoma, Recurrent Childhood Rhabdomyosarcoma, Refractory Childhood Malignant Solid Neoplasm
- Trial name
- NCT07819838
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Volunteers
- 77 people
- Sponsor
- Children's Oncology Group
Refractory Acute Leukemia, Relapsed Acute Leukemia
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias
To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia.
- Conditions
- Refractory Acute Leukemia, Relapsed Acute Leukemia, Undifferentiated Leukemia, Bi-Phenotypic Leukemia
- Trial name
- NCT06466395
- Testing
- Venetoclax, Hyper-CVAD
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- M.D. Anderson Cancer Center
Birth Asphyxia
Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia
The investigators will determine the maximum tolerable dose of sildenafil and establish the pharmacokinetic and pharmacodynamic profile of sildenafil in human asphyxiated neonates treated with hypothermia.
- Trial name
- SANE-02 (NCT04169191)
- Testing
- Sildenafil Citrate
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Brain Tumor, Recurrent, Brain Tumor, Refractory
T Cells Expressing HER2-specific Chimeric Antigen Receptors(CAR) for Patients With HER2-Positive CNS Tumors
This study is for patients that have brain cancer. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers.
- Trial name
- iCAR (NCT02442297)
- Testing
- HER2-specific T cells
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Baylor College of Medicine
Sanfilippo Syndrome (MPS III)
Single Injection of rAAV9-CMV-hNAGLUop Gene for Patients With Mucopolysaccharidosis (MPS) IIIB
The goal of this clinical trial is to learn if one infusion of rAAV9-CMV-hNAGLUop can treat patients with Sanfilippo syndrome (MPS III) 6 months or older.
- Trial name
- NCT07818759
- Testing
- rAAV9-CMV-hNAGLUop
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- NeuroGT
Fibrolamellar Hepatocellular Carcinoma (FLC)
Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA
The aim of this clinical trial is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a DNAJB1-PRKACA fusion transcript-based peptide vaccine (Fusion-VAC-XS15) in patients with FL-HCC or…
- Trial name
- FusionVAC22_02 (NCT06789198)
- Testing
- Vaccination of Fusion-VAC-XS15
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- University Hospital Tuebingen
Glioma, CNS Tumor, Adult
Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
This clinical trial is a 2-phase trial designed to evaluate the safety of tarlatamab in combination with a fixed dose of metronomic temozolomide in adolescents and adults with CNS tumors (stratified into two age-based cohorts)…
- Conditions
- Glioma, CNS Tumor, Adult, CNS Tumor, Childhood
- Trial name
- TARLATEM (NCT07243470)
- Testing
- Tarlatamab, Temozolomide (TMZ)
- Where
- 12 sites in France
- Volunteers
- 70 people
- Sponsor
- Centre Leon Berard
Mantle Cell Lymphoma
A Trial of Obinutuzumab,GDC-0199 Plus Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma Patients
This is an open label, multicenter, fixed dose and dose escalation, phase I/II study. The study will be conducted in 3 steps. The first one (step A) will be to ensure the safety of the combination of Obinutuzumab (GA101) and…
- Trial name
- OAsIs (NCT02558816)
- Testing
- Ibrutinib + GA101 +GDC-0199
- Where
- 9 sites in France, United Kingdom
- Volunteers
- 48 people
- Sponsor
- Nantes University Hospital
Autism Spectrum Disorder, Gastrointestinal Symptoms
Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day…
- Trial name
- NCT03514784
- Testing
- BB-12 with LGG (Higher Dose), BB-12 with LGG (Lower Dose)
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Neoplastic Disease, Solid Tumor
Indocyanine Green (ICG) Guided Tumor Resection
This is a study to assess the ability of Indocyanine Green (ICG) to identify neoplastic disease. For many pediatric solid tumors, complete resection of the primary site and/or metastatic deposits is critical for achieving a cure.
- Trial name
- NCT04084067
- Testing
- Indocyanine Green
- Where
- United States
- Volunteers
- 215 people
- Sponsor
- St. Jude Children's Research Hospital
Leber Congenital Amaurosis
Clinical Gene Therapy Protocol for the Treatment of Retinal Dystrophy Caused by Defects in RPE65
The purpose of the study is to assess the safety and efficacy of the active substance rAAV-2/4.hRPE65 in patients with Leber Congenital Amaurosis or Congenital severe early-onset retinal degeneration associated with RPE65…
- Trial name
- RPE65 (NCT01496040)
- Testing
- rAAV2/4.hRPE65
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Nantes University Hospital
B-cell Acute Lymphoblastic Leukemia, B-cell Non Hodgkin Lymphoma
UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL
This phase I/II trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric…
- Trial name
- NCT04544592
- Testing
- CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- University of Colorado, Denver
Non-hodgkin Lymphoma
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL).
- Trial name
- NCT05206357
- Testing
- Epcoritamab
- Where
- 41 sites in United States, Australia and 12 more
- Volunteers
- 17 people
- Sponsor
- Genmab
T-Cell Non-Hodgkin Lymphoma, T-cell Lymphoma (PTCL and CTCL)
CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas
This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy.
- Trial name
- NCT07022964
- Testing
- CD5 CAR-T cells infusion
- Where
- 3 sites in China
- Volunteers
- 36 people
- Sponsor
- Beijing GoBroad Hospital
Keratoconus
Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking
This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use…
- Trial name
- NCT06235567
- Testing
- Dextenza 0.4Mg Ophthalmic Insert, topical prednisolone acetate 1% (PredForte) eye drops
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Maanasa Indaram, MD
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