Clinical trials: Phase 1
Neurofibromatosis Type 1
Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN
This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints.
- Trial name
- SPRINKLE (NCT05309668)
- Testing
- Selumetinib granule formulation, Selumetinib capsule formulation
- Where
- 16 sites in United States, Germany and 5 more
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
T-cell Acute Lymphoblastic Leukemia, Lymphoma
Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma
This is an open-label, single institution, Phase 1 study of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult participants with relapsed or refractory T-ALL or T-LBL
- Trial name
- NCT07513129
- Testing
- Venetoclax, Dexamethasone, Bortezomib
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Solid Tumors
TT-702 in Patients With Advanced Solid Tumours.
This clinical trial is evaluating the drug candidate TT-702 in patients with advanced solid tumours. The main aims of the trial are to determine the maximum dose of TT-702 that can be given safely to patients alone and in…
- Trial name
- CURATE (NCT05272709)
- Testing
- TT-702, Anti-PD-1 and PD-L1 agent
- Where
- 3 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- Cancer Research UK
Schizophrenia, Schizo-Affective Disorder
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
- Conditions
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I
- Trial name
- NCT05025605
- Testing
- BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
- Where
- 5 sites in United States
- Volunteers
- 140 people
- Sponsor
- BioXcel Therapeutics Inc
T-cell Acute Lymphoblastic Lymphoma, T-non-Hodgkin Lymphoma
Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen
Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer). The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers.
- Conditions
- T-cell Acute Lymphoblastic Lymphoma, T-non-Hodgkin Lymphoma, T-cell Acute Lymphoblastic Leukemia
- Trial name
- MAGENTA (NCT03081910)
- Testing
- Autologous CD5.CAR/28zeta CAR T cells, Allogeneic CD5.CAR/28zeta CAR T cells
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Baylor College of Medicine
Neoplasms
Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
This trial will evaluate long term safety of participants who have received AdaptImmune (ADP) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.
- Trial name
- NCT03391778
- Testing
- ADP adoptive cell therapy
- Where
- 24 sites in United States, Australia and 6 more
- Volunteers
- 250 people
- Sponsor
- USWM CT, LLC
Diarrhea
Safety of Lactobacillus LB Postbiotic in Immunocompromised Paediatric Patients With Diarrhoeal Disease
This prospective, interventional, single-center, open-label, phase 1 clinical trial to assess the safety of the Postbiotic Lactobacillus LB in immunocompromised paediatric patients with diarrhoeal disease will be performed at…
- Trial name
- NCT07758933
- Testing
- Lactobacillus LB
- Where
- Mexico
- Volunteers
- 30 people
- Sponsor
- Hospital Infantil de Mexico Federico Gomez
Malignant Peripheral Nerve Sheath Tumors, MPNST
Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor
People who have a cancer called MPNST, or Malignant Peripheral Nerve Sheath Tumor, may be eligible for this study. The purpose of this study is to see if a new medicine called BMS-986504 may work better than other available…
- Trial name
- NCT07549022
- Testing
- BMS-986504
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Ankit Mangla, MD
Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia, Refractory
Evaluation of CD19-Specific CAR Engineered Autologous T-Cells for Treatment of Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia
SJCAR19 is a research study seeking to evaluate the use of chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of pediatric, adolescent and young adult patients with relapsed or…
- Trial name
- NCT03573700
- Testing
- Cyclophosphamide, Fludarabine, Mesna
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- St. Jude Children's Research Hospital
Obstructive Sleep Apnea
DRonabinol Treatment of OSA
This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take oral Dronabinol for two weeks.
- Trial name
- DROSA (NCT06477952)
- Testing
- Dronabinol
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- VA Office of Research and Development
Duchenne Muscular Dystrophy (DMD)
Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-251 in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
The primary purpose of this study is to evaluate the safety, tolerability, and dystrophin protein levels in muscle tissue following multiple intravenous (IV) doses of DYNE-251 in participants with Duchenne muscular dystrophy…
- Trial name
- DELIVER (NCT05524883)
- Testing
- DYNE-251
- Where
- 30 sites in United States, Australia and 7 more
- Volunteers
- 86 people
- Sponsor
- Dyne Therapeutics
Diffuse Midline Glioma, H3 K27M-Mutant
CAR T Cells to Target GD2 for DMG
The CARMIGO Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children and young adults aged 2-16 years with Diffuse Midline Glioma…
- Trial name
- CARMIGO (NCT05544526)
- Testing
- GD2 CAR T cells
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- University College, London
Blood Cancer
Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies
KCAT19 is a single-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age 16-65 years) with high risk, relapsed/refractory (r/r) B cell…
- Trial name
- KCAT19 (NCT05391490)
- Testing
- KCAT19 T cells
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- University College, London
Primary CNS Lymphoma
Immunotherapy Using CAR T-cells to Target CD19 for Relapsed/Refractory CD19+ Primary CNS Lymphoma
The CAROUSEL Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age ≥16) with relapsed/refractory Primary CNS Lymphoma.
- Trial name
- CAROUSEL (NCT04443829)
- Testing
- CD19CAR T-cells
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- University College, London
Synovial Sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST)
SPEARHEAD-3 Pediatric Study
This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers.
- Conditions
- Synovial Sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Neuroblastoma (NBL), Osteosarcoma
- Trial name
- NCT05642455
- Testing
- Afamitresgene autoleucel
- Where
- 10 sites in United States
- Volunteers
- 20 people
- Sponsor
- USWM CT, LLC
Hypertension in Pregnancy
Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project
The CHAP2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (HTN) in pregnancy improves maternal and or neonatal outcomes.
- Trial name
- CHAP2 (NCT05989581)
- Testing
- Labetalol or Nifedipine
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Homocystinuria
Pegtibatinase as a Treatment for Patients With Classical Homocystinuria (HCU) (Also Known as the COMPOSE Study)
Researchers are looking for a better way to treat people who have classical homocystinuria (HCU), a rare condition that is passed down by parents (or "genetic condition").
- Trial name
- NCT03406611
- Testing
- Pegtibatinase
- Where
- 12 sites in United States, France and 1 more
- Volunteers
- 39 people
- Sponsor
- Travere Therapeutics, Inc.
Staphylococcal Aureus Infection, Microbial Colonization
Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment
- Conditions
- Staphylococcal Aureus Infection, Microbial Colonization, Pediatric Infection, S. Aureus Colonization
- Trial name
- NMT Protocol 3 (NCT06805994)
- Testing
- Nasal Microbiota Transplant (NMT)
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
DNMT3A Gene Mutation
Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia
This is a prospective, single-arm clinical study evaluating the efficacy and safety of metformin in inhibiting DNMT3A R882-driven clonal hematopoiesis (CH) in patients with acute leukemia (AL) who are in remission and under…
- Trial name
- NCT07188740
- Testing
- Metformin
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Hematopoietic Stem Cell Transplantation
Zoledronate to Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors
The purpose of this pilot study is to investigate the safety and preliminarily assess efficacy of early intervention with zoledronate in high risk pediatric hematopoietic stem cell transplantation (HSCT) patients to prevent the…
- Trial name
- NCT07375290
- Testing
- Zoledronate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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