Clinical trials: Phase 1
Pediatric HIV Infection, Tuberculosis Infection
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV/TB cotreatment strategies in children.
- Trial name
- NCT05069688
- Testing
- rifampicin
- Where
- Nigeria
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
Refractory Lupus Nephritis, Systemic Sclerosis
CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension…
- Conditions
- Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension, Other Autoimmune Diseases (AID)
- Trial name
- NCT06947460
- Testing
- CD19-BCMA CAR-T cells infusion
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Beijing GoBroad Hospital
Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Malignant Glioma
Savolitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors
This phase I trial studies the side effects and best dose of savolitinib in treating patients with primary central nervous system (CNS) tumors that have come back (recurrent) or does not respond to treatment (refractory).
- Conditions
- Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Primary Central Nervous System Neoplasm
- Trial name
- NCT03598244
- Testing
- Biospecimen Collection, Magnetic Resonance Imaging, Savolitinib
- Where
- 12 sites in United States, Canada
- Volunteers
- 41 people
- Sponsor
- National Cancer Institute (NCI)
Solid Tumors, Neuroblastoma
Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors
A pilot pharmacokinetic trial to determine the safety and efficacy of a flavored, orally administered irinotecan VAL-413 (Orotecan®) given with temozolomide for treatment of recurrent pediatric solid tumors including but not…
- Conditions
- Solid Tumors, Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma
- Trial name
- NCT04337177
- Testing
- VAL-413, Temozolomide
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Valent Technologies, LLC
Sickle Cell Disease
TMLI and Alemtuzumab for Treatment of Sickle Cell Disease
This phase I trial tests the safety and effectiveness of total marrow and lymphoid irradiation (TMLI) and alemtuzumab as a conditioning regimen in patients with sickle cell disease.
- Trial name
- NCT05384756
- Testing
- Alemtuzumab, Hematopoietic Cell Transplantation, Intensity-Modulated Radiation Therapy
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
Synovial Sarcoma, Myxoid/Round Cell Liposarcoma
Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1
The goal of this clinical research study is to find a recommended dose of donated NK cells that can be given along with chemotherapy to patients with advanced cancers. The safety and effects of this therapy will also be studied.
- Trial name
- NCT06083883
- Testing
- Fludarabine phosphate, NY-ESO-1 TCR/IL-15 NK, Cyclophosphamide
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- M.D. Anderson Cancer Center
Sickle Cell Disease
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications…
- Trial name
- R34 pK/PD (NCT02447874)
- Testing
- Arginine, Arginine (Loading), Arginine (Continuous)
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Emory University
Central Nervous System Tumors
Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors
This study consists of 2 parts: Dose Escalation Part 1 and Dose Expansion Part 2. The Dose Escalation Part 1 will evaluate the safety and tolerability of Avelumab in combination with Lenvatinib and determine the recommended…
- Trial name
- NCT05081180
- Testing
- Avelumab, Lenvatinib
- Where
- 9 sites in Canada, France and 2 more
- Volunteers
- 17 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Clift Lip, Cleft Palate
Description of Pain in Pediatric Patients With Cleft Lip and Palate Undergoing Alveolar Grafting Using Two Surgical Strategies: Stem Cells and Autogenous Iliac Crest Bone (Pain Evaluation in Children Undergoing Alveolar Grafting: Stem Cells vs. Iliac Crest Bone)
Study Objective The objective of this study was to evaluate and compare postoperative pain and hospital costs in pediatric patients with cleft lip and palate undergoing alveolar bone grafting surgery.
- Conditions
- Clift Lip, Cleft Palate, Alveolar Bone Loss, Postoperative Pain
- Trial name
- NCT07734974
- Testing
- Autogenous Iliac Crest Bone Grafting, Bioengineered Alveolar Grafting (SHED + Scaffold)
- Where
- Brazil
- Volunteers
- 20 people
- Sponsor
- Hospital Sirio-Libanes
Type 1 Diabetes Mellitus
Siplizumab in T1DM
This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0.
- Trial name
- DESIGNATE (NCT05574335)
- Testing
- Siplizumab
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Opioid-Induced Constipation (OIC)
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive…
- Trial name
- NCT05588323
- Testing
- Naldemedine
- Where
- 16 sites in Albania, Armenia and 6 more
- Volunteers
- 24 people
- Sponsor
- Shionogi
White Matter Injury, Brain Injury, Fetus and Neonate
Neonatal White Matter Injury Trial (WRAP)
The researchers are investigating a new treatment for white matter injury, which is a common type of brain injury in premature babies. The drug, clemastine, is experimental.
- Conditions
- White Matter Injury, Brain Injury, Fetus and Neonate, Neonatal Brain Injury, Periventricular Leukomalacia
- Trial name
- WRAP (NCT07688746)
- Testing
- Clemastine fumarate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Bridget LaMonica Ostrem, M.D., Ph.D.
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics
Progressive Pediatric Brain Cancer
Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer
This is a open label Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme, in…
- Trial name
- NCT07732413
- Testing
- NLG802 (indoximod Prodrug), Temozolomide
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Lumos Pharma
Phelan-McDermid Syndrome, SHANK3 Haploinsufficiency
RB001 Gene Therapy Study in Children With SHANK3-related Phelan-McDermid Syndrome (PMS)
This is an open-label, dose-escalation study to evaluate the safety, tolerability, and clinical activity of a single dose of RB001 administered via intracerebroventricular (ICV) injection in pediatric with SHANK3 related…
- Trial name
- NCT07014020
- Testing
- RB001
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Peking University First Hospital
Erythropoietic Protoporphyria
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.
- Trial name
- NCT06388642
- Testing
- Afamelanotide 16mg implant
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 28 people
- Sponsor
- Clinuvel Europe Limited
Diffuse Large B-Cell Lymphoma (DLBCL), Hodgkin Lymphoma
Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)
This Phase I study will evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes modified to express a constitutively active IL7 receptor (C7R) and a chimeric antigen receptor (CAR) for CD30…
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL), Hodgkin Lymphoma, Peripheral T-cell Lymphoma (PTCL), Anaplastic Large Cell Lymphoma, ALK-Positive
- Trial name
- ANCILE-30 (NCT07729397)
- Testing
- Autologous C7R.CD30-CAR-EBVSTs
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- The Methodist Hospital Research Institute
Atopic Dermatitis
Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children
The study aims to evaluate the clinical efficacy of Chinese medicine (CM) for the treatment of subacute and chronic Atopic Dermatitis (AD) patients when compared to the placebo control by examining the clinical symptoms.
- Trial name
- NCT05613062
- Testing
- Modified Huang-Lian-Jie-Du Decoction (MHLJDD)
- Where
- Hong Kong
- Volunteers
- 20 people
- Sponsor
- Chinese University of Hong Kong
Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV)
Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis
- Conditions
- Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV), Juvenile Myasthenia Gravis, Juvenile Dermatomyositis
- Trial name
- NCT07089121
- Testing
- Descartes-08
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cartesian Therapeutics
Angelman Syndrome
A Phase 1/2 Study of the Safety and Efficacy of MVX-220 in Angelman Syndrome
The purpose of this study is to evaluate the safety and efficacy of MVX-220 gene therapy in children and adults with Angelman syndrome with UBE3A gene deletion, uniparental disomy, or imprinting center defect genotypes.
- Trial name
- ASCEND-AS (NCT07181837)
- Testing
- MVX-220
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- MavriX Bio, LLC
The first 1,020 results can be paged through. Add a filter or change the sort order to reach the rest.