Clinical trials: Phase 1
Tuberculosis, HIV Infections
Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa
The purpose of this study is to assess whether Mycobacterium bovis rBCGΔureC::hly (VPM1002) vaccination and Mycobacterium bovis bacille Calmette-Guérin (BCG) revaccination are safe and immunogenic in pre-adolescents with and…
- Trial name
- NCT05539989
- Testing
- VPM1002 Vaccine, BCG Vaccine
- Where
- 9 sites in South Africa
- Volunteers
- healthy volunteers welcome
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Bacterial Infections
Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections
A single dose infusion of Vabomere (meropenem-vaborbactam) is being tested for dose-finding, pharmacokinetics, safety, and tolerability in pediatric subjects from birth to less than 18 years of age with serious bacterial…
- Trial name
- TANGOKIDS (NCT02687906)
- Testing
- Vabomere
- Where
- 9 sites in United States
- Volunteers
- 39 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
Malignant Primary Gliomas, Glioblastoma Multiform (Grade IV Astrocytoma)
5G-EMERALD: Amivantamab in Malignant Brain Tumours
The purpose of this clinical trial is to evaluate the safety and tolerability of amivantamab and to determine the preliminary antitumour activity of amivantamab administered at the recommended Phase 2 dose (RP2D).
- Conditions
- Malignant Primary Gliomas, Glioblastoma Multiform (Grade IV Astrocytoma), Diffuse Hemispheric Glioma, H3 G34-Mutant, Glioblastoma Multiforme (GBM)
- Trial name
- 5G-EMERALD (NCT06632236)
- Testing
- Amivantamab
- Where
- 2 sites in United Kingdom
- Volunteers
- 12 people
- Sponsor
- Institute of Cancer Research, United Kingdom
Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
- Trial name
- NCT06927466
- Testing
- B019
- Where
- 8 sites in China
- Volunteers
- 33 people
- Sponsor
- Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.
Hepatitis C
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection…
- Trial name
- NCT07040319
- Testing
- Glecaprevir/pibrentasvir
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Single-ventricle, Infant Conditions
PK/PD of Digoxin in Infants With SVHD
The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in…
- Conditions
- Single-ventricle, Infant Conditions, Infant, Newborn, Diseases, Infant, Premature, Diseases
- Trial name
- Digoxin R01 (NCT06613477)
- Testing
- PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Duke University
Viral Infection
Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis
This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus.
- Trial name
- NCT03594981
- Testing
- CMV/AdV /EBV/BKV specific T cells
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Catherine Bollard
Refractory Neuroblastoma, Relapsed Neuroblastoma
GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma and Metastatic Retinoblastoma
This is a first in human dose escalation trial to determine the safety of administering GPC2 CAR T cells in patients with advanced neuroblastoma or retinoblastoma.
- Conditions
- Refractory Neuroblastoma, Relapsed Neuroblastoma, High-risk Neuroblastoma, Retinoblastoma
- Trial name
- GPC2 (NCT05650749)
- Testing
- GPC2 CAR T cells
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Stephan Grupp MD PhD
ALK Fusion-positive Solid or CNS Tumors
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is…
- Trial name
- NCT04774718
- Testing
- Alectinib
- Where
- 31 sites in United States, Australia and 9 more
- Volunteers
- 42 people
- Sponsor
- Hoffmann-La Roche
Hypoxic-Ischemic Encephalopathy
Dose Optimization of Caffeine for HIE
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
- Trial name
- NCT06448780
- Testing
- Caffeine citrate 20 mg/kg, Caffeine citrate 30 mg/kg
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- University of North Carolina, Chapel Hill
Brain Tumor
Multi-antigen T Cell Infusion Against Neuro-oncologic Disease
This Phase I dose-escalation trial is designed to determine the safety and feasibility of rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) in patients with newly diagnosed diffuse…
- Trial name
- REMIND (NCT03652545)
- Testing
- TAA-T
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Catherine Bollard
Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS
Multi-institutional Prospective Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies
This Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS.
- Trial name
- RESOLVE (NCT02203903)
- Testing
- Tumor associated antigen lymphocytes (TAA-T)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Catherine Bollard
Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma
This is a Phase I, open-label multi-site trial designed to evaluate the safety of administering rapidly-generated Tumor associated antigen specific T cells (TAA-T) with the Programmed Death1 (PD-1) inhibitor Nivolumab, in…
- Trial name
- NCT03843294
- Testing
- TAA-T cells, Nivolumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Catherine Bollard
Duchenne Muscular Dystrophy (DMD)
A Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 45 Skipping to Evaluate the Safety and Efficacy of ENTR-601-45
This is a study of the investigational medicine ENTR-601-45 in participants who have Duchenne muscular dystrophy (DMD), a rare genetic condition.
- Trial name
- ELEVATE-45 (NCT07038824)
- Testing
- ENTR-601-45
- Where
- 15 sites in Belgium, Italy and 3 more
- Volunteers
- 24 people
- Sponsor
- Entrada Therapeutics, Inc.
Rhabdomyosarcoma, Ewing Sarcoma
Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME Tumor Antigen-specific T cells) following lymphodepleting chemotherapy…
- Conditions
- Rhabdomyosarcoma, Ewing Sarcoma, Neuroblastoma, Wilms Tumor
- Trial name
- SABRE (NCT07172958)
- Testing
- Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Children's National Research Institute
B-Acute Lymphoblastic Leukemia, CAR-T Cell Therapy
Pre-emptive Anakinra for Cytokine Event Reduction
Objectives: The primary objective of this study will be to evaluate the impact of pre-emptive use of anakinra on the rate of severe cytokine release syndrome (CRS) following CD19-directed chimeric antigen receptor (CAR) T-cell…
- Conditions
- B-Acute Lymphoblastic Leukemia, CAR-T Cell Therapy, Cytokine Release Syndrome, Immune Effector Cell Associated Neurotoxicity Syndrome
- Trial name
- PACER (NCT06703216)
- Testing
- Anakinra (Kineret®)
- Where
- United States
- Sponsor
- Kevin McNerney
Sickle Cell Anemia, Beta-thalassemia Major
T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias
The purpose of this study is to evaluate what effect, if any, mismatched unrelated volunteer donor and/or haploidentical related donor stem cell transplant may have on severe sickle cell disease and other transfusion dependent…
- Conditions
- Sickle Cell Anemia, Beta-thalassemia Major, Diamond-blackfan Anemia
- Trial name
- NCT03653338
- Testing
- CD3/CD19 depleted leukocytes, CD45RA depleted leukocytes, Hydroxyurea
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Paul Szabolcs
Duchenne Muscular Dystrophy (DMD)
A Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 44 Skipping to Evaluate the Safety and Efficacy of ENTR-601-44
This is a study of the investigational medicine ENTR-601-44 in participants who have Duchenne muscular dystrophy (DMD), a rare genetic condition.
- Trial name
- ELEVATE-44 (NCT07037862)
- Testing
- ENTR-601-44
- Where
- 14 sites in Belgium, Italy and 2 more
- Volunteers
- 24 people
- Sponsor
- Entrada Therapeutics, Inc.
Cerebral Palsy (CP)
Intrathecal Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells for Children With Cerebral Palsy
This is a single-center, open-label, single-arm Phase I pilot study designed to evaluate the feasibility and short-term safety of a single intrathecal administration of allogeneic umbilical cord tissue-derived mesenchymal stromal…
- Trial name
- NCT07763028
- Testing
- allogeneic umbilical cord tissue-derived mesenchymal stromal cells (UCT-MSCs)
- Where
- Indonesia
- Volunteers
- 7 people
- Sponsor
- Gadjah Mada University
Glioblastoma Multiforme, High-grade Astrocytoma Not Otherwise Specified (NOS)
Phase I Study of APX005M in Pediatric Central Nervous System Tumors
This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing, spreading, or getting worse (progressive), or newly diagnosed…
- Conditions
- Glioblastoma Multiforme, High-grade Astrocytoma Not Otherwise Specified (NOS), CNS Primary Tumor, Not Otherwise Specified (NOS), Ependymoma, Not Otherwise Specified (NOS)
- Trial name
- NCT03389802
- Testing
- APX005M treatment for recurrent or refractory primary malignant CNS tumor patients, APX005M treatment for newly diagnosed DIPG patients
- Where
- 11 sites in United States
- Volunteers
- 32 people
- Sponsor
- Pediatric Brain Tumor Consortium
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