Clinical trials: Phase 1
Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm
Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer
This phase I trial studies the side effects and best dose of vandetanib and everolimus when given together in treating patients with cancer that has spread to other places in the body.
- Conditions
- Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm
- Trial name
- NCT01582191
- Testing
- Everolimus, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- M.D. Anderson Cancer Center
To Assess the Feasibility, Visualization Capability, and Optimal Dosing of ICG Fluorescence Imaging for Intraoperative Assessment of Knee Tissue Perfusion
ICG Fluorescence in Knee Arthroscopy Study
The purpose of this study is to first evaluate whether ICG fluorescence angiography can be used to evaluate blood flow of the anterior cruciate ligament (ACL), tendons, and knee structures during an arthroscopic surgery.
- Trial name
- NCT07793266
- Testing
- Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose), Intravenous administration of indocyanine green (SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose), Intravenous administration of indocyanine green (SPY Agent Green) 4 mL of SPY Agent Green (10 mg dose)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Henry Ford Health System
Busulfan Pharmacokinetic Analysis, Busulfan Dosing
26DT052; Scaling Busulfan Dose to Body Surface Area in Children
The goal of this pilot study is to determine if scaling the first busulfan dose to Body Surface Area (BSA) in children with a BSA ≥0.5 m2 and using a BSA-banded dosing table for infants (BSA <0.5 m2) increases the fraction of…
- Conditions
- Busulfan Pharmacokinetic Analysis, Busulfan Dosing, Hematopoietic Stem Cell Transplant (HSCT), Busulfan
- Trial name
- NCT07792369
- Testing
- Busulfan (BU)
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Children's Hospital of Philadelphia
Electrical Status Epilepticus of Slow-Wave Sleep
Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).
This study aims to assess the efficacy of Epidiolex in patients with ESES. ESES is characterized by sleep potentiated spikes with a spike index greater than 85% (conventional definition) and 50% (new definition)1.
- Trial name
- NCT04721691
- Testing
- Epidiolex 100 mg/mL Oral Solution
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Northwell Health
Relapsed Pediatric ALL, Hematopoietic Cell Transplantation
CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL.
- Conditions
- Relapsed Pediatric ALL, Hematopoietic Cell Transplantation, Hematologic Malignancy
- Trial name
- NCT07257419
- Testing
- Anti-Thymocyte Globulin (Rabbit), Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- St. Jude Children's Research Hospital
UC - Ulcerative Colitis
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants
This Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and cytokine profiles of LYNC-101 for Injection in healthy adult participants.
- Trial name
- NCT07505030
- Testing
- LYNC-101
- Where
- Australia
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- LyncBio Therapeutics Co., Ltd.
AADC Deficiency
A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients
The overall objective of this study is to determine the safety and efficacy of AAV2-hAADC delivered to the substantia nigra pars compacta (SNc) and ventral tegmental area (VTA) in children with aromatic L-amino acid decarboxylase…
- Trial name
- AADC (NCT02852213)
- Testing
- AAV2-hAADC
- Where
- 3 sites in United States
- Volunteers
- 42 people
- Sponsor
- Krzysztof Bankiewicz
GJB2-mediated Hearing Loss, GJB2 Gene Mutation
Open-label Study of SKY-GJB2 in Pediatric Subjects With GJB2-mediated Hearing Loss
Skylark Bio is conducting a study of an investigational new drug called SKY-GJB2 and its delivery device, the SKY-CAT. SKY-GJB2 is a gene therapy that is being developed to treat children who have hearing loss due to changes in…
- Conditions
- GJB2-mediated Hearing Loss, GJB2 Gene Mutation, DFNB1A
- Trial name
- SONIX (NCT07627971)
- Testing
- SKY-GJB2
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Skylark Bio Inc.
Hodgkin Lymphoma, Non Hodgkin Lymphoma
A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.
PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population.
- Trial name
- PEGASUS (NCT06383338)
- Testing
- Omeprazole, Dextromethorphan
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Murdoch Childrens Research Institute
Netherton Syndrome
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
This is a first-in-human, Phase 1/1b, 4-part study that includes the evaluation of safety, tolerability, pharmacokinetics (PK), and immunogenicity of BCX17725 when administered via single and multiple doses in healthy adult…
- Trial name
- NCT06539507
- Testing
- BCX17725
- Where
- 12 sites in United States, Australia and 3 more
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Urea Cycle Disorders, Carbamoyl-Phosphate Synthase I Deficiency
Study of LNP.UCD.ABE in Patients With Urea Cycle Disorders
This is a single-site Phase 1/2 open-label umbrella clinical trial designed to evaluate the safety, tolerability, and efficacy of a single intravenous dose of LNP.UCD.ABE in 5 pediatric subjects with severe infantile-onset UCDs.
- Trial name
- NCT07667387
- Testing
- LNP.UCD.ABE
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Rebecca Ahrens-Nicklas
Advanced Solid Tumor, Metastatic Solid Tumor
Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
This is a first-in-human, multicenter, open-label, phase 1 study to evaluate safety, tolerability, and efficacy of CID-078, a Cyclin A/B-RxL inhibitor, in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Refractory Solid Tumor, Cancer
- Trial name
- NCT06577987
- Testing
- CID-078 Monotherapy
- Where
- 10 sites in United States
- Volunteers
- 220 people
- Sponsor
- Circle Pharma
HIV-1-infection
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
The goal of this clinical study is to learn more about the study drug, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), safety, tolerability, and pharmacokinetics (how B/F/TAF is absorbed, modified, distributed, and…
- Trial name
- NCT07055451
- Testing
- B/F/TAF
- Where
- 7 sites in United States, South Africa
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
Lymphoblastic Leukemia, Acute, Childhood, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Study for Safety and Efficacy of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Ph + ALL
This is an open-label, multicenter, phase 1b study, which is designed to explore the safety, efficacy and PK of olverembatinib, a third-generation tyrosine kinase inhibitor (TKI) marketed in China, in combination with APG-2575 in…
- Conditions
- Lymphoblastic Leukemia, Acute, Childhood, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, Relapsed Leukemia, Refractory Leukemia
- Trial name
- NCT05495035
- Testing
- Olverembatinib, APG-2575, Dexamethasone
- Where
- 4 sites in China
- Volunteers
- 19 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia
Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling
Functional precision medicine (FPM) is a relatively new approach to cancer therapy based on direct exposure of patient- isolated tumor cells to clinically approved drugs and integrates ex vivo drug sensitivity testing (DST) and…
- Conditions
- Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Large Cell Lymphoma, Refractory Childhood Acute Lymphoblastic Leukemia
- Trial name
- NCT05857969
- Testing
- Functional Precision Medicine
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Florida International University
Adult Acute Myeloid Leukemia in Remission, Acute Biphenotypic Leukemia
Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
This phase I trial studies the side effects and the best dose of genetically modified T-cells after lymphodepleting chemotherapy in treating patients with acute myeloid leukemia or blastic plasmacytoid dendritic cell neoplasm…
- Conditions
- Adult Acute Myeloid Leukemia in Remission, Acute Biphenotypic Leukemia, Early Relapse of Acute Myeloid Leukemia, Late Relapse of Acute Myeloid Leukemia
- Trial name
- NCT02159495
- Testing
- cyclophosphamide, Autologous CD123CAR-CD28-CD3zeta-EGFRt-expressing T Lymphocytes, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- City of Hope Medical Center
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM)
This research study uses special blood cells called multiple tumor-associated antigen (TAA)-specific T cells (a new experimental therapy) to treat patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) which…
- Trial name
- NCT02494167
- Testing
- MultiTAA-specific T cells
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Baylor College of Medicine
Acute T Cell Lymphoblastic Leukemia, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory
A Clinical Study of HY035 Cell Injection in the Treatment of CD7-positive Relapsed or Refractory Hematologic Malignancies
This study is a single-arm, open-label, non-randomized clinical trial aimed at evaluating the safety, tolerability and preliminary efficacy of HY035 cell injection in the treatment of patients with CD7-positive relapsed or…
- Conditions
- Acute T Cell Lymphoblastic Leukemia, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory, Acute Myeloid Leukemia (AML), T Cell Lymphoma
- Trial name
- NCT07784309
- Testing
- HY035 cell injection
- Where
- China
- Volunteers
- 13 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Juvenile Myelomonocytic Leukemia
- Trial name
- NCT04726241
- Testing
- Biospecimen Collection
- Where
- 184 sites in United States, Australia and 3 more
- Volunteers
- 960 people
- Sponsor
- PedAL BCU, LLC
Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Myelodysplastic Syndrome
A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy
This phase I trial tests the safety, side effects, and best dose of imetelstat in combination with fludarabine and cytarabine in treating patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or juvenile…
- Conditions
- Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Myelodysplastic Syndrome, Recurrent Juvenile Myelomonocytic Leukemia, Refractory Childhood Acute Myeloid Leukemia
- Trial name
- NCT06247787
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Where
- 19 sites in United States
- Volunteers
- 36 people
- Sponsor
- Children's Oncology Group
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