Clinical trials: Phase 1
Leukemia, Juvenile Myelomonocytic, JMML
A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia
This clinical trial will test the safety and efficacy of combining trametinib and azacitidine in patients with juvenile myelomonocytic leukemia (JMML).
- Conditions
- Leukemia, Juvenile Myelomonocytic, JMML, JCML, Neurofibromatosis 1
- Trial name
- NCT05849662
- Testing
- Trametinib, Azacitidine, Fludarabine
- Where
- 21 sites in United States
- Volunteers
- 58 people
- Sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
Recurrent Neuroblastoma, Refractory Neuroblastoma
Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma
This phase I trial studies the side effects and best dose of lenalidomide when given together with dinutuximab with or without isotretinoin in treating younger patients with neuroblastoma that does not respond to treatment or…
- Trial name
- NCT01711554
- Testing
- Dinutuximab, Isotretinoin, Laboratory Biomarker Analysis
- Where
- 15 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- National Cancer Institute (NCI)
Staphylococcus Aureus, Microbial Colonization
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.
- Conditions
- Staphylococcus Aureus, Microbial Colonization, Neonatal Infection
- Trial name
- NCT06283355
- Testing
- Nasal Microbiota Transplant (NMT)
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Mucopolysaccharidosis III-A
Phase I/II Study of JR-441 in Patients With Mucopolysaccharidosis Type IIIA
A Phase I/ II, open-label, randomized, 2-arm study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of MPS IIIA patients.
- Trial name
- NCT06095388
- Testing
- JR-441
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- JCR Pharmaceuticals Co., Ltd.
Leukemia, B-Cell
Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)
This is a gene transfer study for patients with a type of blood cancer called Acute Lymphoblastic Leukemia (ALL) that has come back or has not gone away after treatment.
- Trial name
- TRICAR-ALL (NCT05010564)
- Testing
- Autologous TRICAR-ALL T-cells and lymphodepletion chemotherapy
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Baylor College of Medicine
Acute Myeloid Leukemia
A Phase Ia/Ib Open-label, Multiple Dose, Study to Determine the Recommended Dose, Evaluate PKs, PDs, Safety, and Activity of Venetoclax in Combination With Oral Decitabine/Cedazuridine (ASTX727) in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
To find a recommended dose of ASTX727 (cedazuridine/decitabine) in combination with venetoclax for pediatric patients with relapsed AML.
- Trial name
- NCT06191978
- Testing
- ASTX727, Venetoclax
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- M.D. Anderson Cancer Center
Hematologic Malignancies
Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
SLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with…
- Trial name
- NCT04588922
- Testing
- SLS009, venetoclax, azacitidine
- Where
- 32 sites in United States, China
- Volunteers
- 160 people
- Sponsor
- Sellas Life Sciences Group
Chronic Disease, Mental Health
Alaska Alliance for Community Engagement Phase II: Partnership for Action Toward Health
The AK ACE-PATH Phase II study aims to pilot and implement a novel intervention, Tools for Arctic Health Promotion (TAHP), to address Alaska Native (AN) community priorities related to local health and community-level resilience.
- Conditions
- Chronic Disease, Mental Health, Caridovascular Disease, Stress
- Trial name
- AK ACE-PATH (NCT07801989)
- Testing
- Tools for Arctic Health Promotion
- Where
- United States
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- University of Alaska Fairbanks
Friedreich Ataxia
A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old
In this study, researchers will learn more about BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich's Ataxia (FA) who are at…
- Trial name
- BOLD (NCT06054893)
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Biogen
Atypical Teratoid/Rhabdoid Tumor, Embryonal Tumor With Multilayered Rosettes
Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas
The purpose of this study is to evaluate the investigational oral drug AMXT 1501 in combination with oral eflornithine (DFMO). An investigational drug is one that has not been approved by the U.S.
- Conditions
- Atypical Teratoid/Rhabdoid Tumor, Embryonal Tumor With Multilayered Rosettes, Ewing Sarcoma, Diffuse Intrinsic Pontine Glioma
- Trial name
- NCT06465199
- Testing
- Eflornithine (DFMO), AMXT 1501 Dicaprate
- Where
- 14 sites in United States
- Volunteers
- 265 people
- Sponsor
- Milton S. Hershey Medical Center
Central Nervous System Neoplasms, Brain Tumor
B7-H3.CD28Z.CART in CNS Neoplasms
The purpose of this research study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors.
- Conditions
- Central Nervous System Neoplasms, Brain Tumor, Brain Tumor, Recurrent, Brain Tumor, Pediatric
- Trial name
- NCT07390539
- Testing
- B7-H3.CD28Z.CART, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 70 people
- Sponsor
- Robbie Majzner
Osteosarcoma Metastatic, Soft Tissue Sarcoma (STS)
A Study to Assess Safety and Efficacy of SOT106 in Patients With LRRC15-positive Advanced Unresectable or Metastatic Osteosarcoma or Soft Tissue Sarcoma
SOT106 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called LRRC15, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B.
- Conditions
- Osteosarcoma Metastatic, Soft Tissue Sarcoma (STS), Osteosarcoma, Advanced
- Trial name
- NCT07801222
- Testing
- SOT106
- Where
- Moldova
- Volunteers
- 70 people
- Sponsor
- SOTIO Biotech a.s.
Pediatric Solid Tumor, Neuroblastoma
B7-H3.CD28Z.CART in Solid Tumors
The goal of this research study is to test if a new cell therapy (B7-H3.CD28Z.CART / B7-H3 CAR T cells) is safe and effective in treating children and young adults with solid cancers whose tumors have returned or stopped…
- Trial name
- NCT07358260
- Testing
- B7-H3.CD28Z.CART, Fludarabine, Cyclophosphamide
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Robbie Majzner
Muscular Atrophy, Spinal
A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)
In this PIERRE-PK study, researchers will learn how the body processes nusinersen when it is given through the ThecaFlex DRx™ System, compared to when nusinersen is given by lumbar puncture (LP).
- Trial name
- PIERRE-PK (NCT06555419)
- Testing
- Nusinersen, ThecaFlex DRx System
- Where
- 21 sites in United States, France and 5 more
- Volunteers
- 78 people
- Sponsor
- Biogen
SHANK3 Haploinsufficiency, Phelan-McDermid Syndrome
JAG201 Gene Therapy Study in Children & Adults With SHANK3 Haploinsufficiency
This is a Phase 1/2, first in human, open-label, dose-escalation study to evaluate the safety, tolerability, and clinical activity of a single dose of JAG201 administered via intracerebroventricular (ICV) injection in pediatric…
- Trial name
- NCT06662188
- Testing
- JAG201
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Jaguar Gene Therapy, LLC
X-Linked Myotubular Myopathy
Study of ASP2957 in Male Participants With X-linked Myotubular Myopathy Who Need Ventilators
X-linked myotubular myopathy (XLMTM) is a rare and serious condition present at birth where the muscles do not work properly. There are currently no approved therapies for XLMTM.
- Trial name
- NCT07052929
- Testing
- ASP2957, Methylprednisolone, Prednisolone
- Where
- 5 sites in United States, Canada
- Volunteers
- 9 people
- Sponsor
- Astellas Gene Therapies
Neuroendocrine Tumors
A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use
A [68]Ga-HA-DOTATATE PET/CT or PET/MRI scan is a nuclear medicine test used to create pictures of the whole body that will show where somatostatin receptors are found, including on tumours.
- Trial name
- NCT03145857
- Testing
- [68]Ga-HA-DOTATATE
- Where
- Canada
- Volunteers
- 634 people
- Sponsor
- AHS Cancer Control Alberta
MF With Splenomegaly
Evaluating Safety ,Tolerability, Pharmacokinetic,Efficacy of WJ01024 or WJ01024 Combined With Ruxolitinib in Patients With Myelofibrosis
This is a Phase I clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics and preliminary efficacy of oral WJ01024 administered as monotherapy and in combination with ruxolitinib in patients with…
- Trial name
- NCT07802405
- Testing
- WJ01024 tablet
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Henan Cancer Hospital
Refractory Acute Leukemia, Pediatric Relapsed
A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias
To find the highest safe dose of ziftomenib that can be combined with venetoclax and azacitidine in pediatric participants with acute leukemia that has certain types of genetic mutations (changes).
- Trial name
- NCT06397027
- Testing
- Ziftomenib, Venetoclax, Azacitidine
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- M.D. Anderson Cancer Center
Ewing Sarcoma, Osteosarcoma
Cabozantinib With Ifosfamide in Relapsed/Refractory Sarcomas
The purpose of this study is to better understand how safe and effective the drug cabozantinib in combination with high-dose ifosfamide is in the treatment of children and adults with relapsed/refractory sarcomas.
- Conditions
- Ewing Sarcoma, Osteosarcoma, Sarcomas
- Trial name
- NCT06156410
- Testing
- Cabozantinib
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Children's Hospital of Philadelphia
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