Clinical trials: Phase 1
X-Linked Chronic Granulomatous Disease
Study of EN-374 Gene Therapy in Participants With X-Linked Chronic Granulomatous Disease
The goal of this clinical trial is to evaluate the safety and potential efficacy of the EN-374 treatment regimen and identify a dose level for further evaluation in participants with x-linked chronic granulomatous disease.
- Trial name
- NCT06876363
- Testing
- EN-374
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 15 people
- Sponsor
- Ensoma
Propionic Acidemia
AAVrh10-PCCA Gene Therapy for Propionic Acidemia
Propionic acidemia is a genetic metabolic disorder characterized by metabolic acidosis, ketosis, vomiting, lethargy, cognitive impairment, and risk of death.
- Trial name
- NCT07643844
- Testing
- AAVrh10-PCCA low dose, AAVrh10-PCCA middle dose, AAVrh10-PCCA high dose
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Mayo Clinic
Neuroblastoma, Solid Tumor
APG-115 Alone or in Combination With APG-2575 in Recurrent or Refractory Neuroblastoma or Solid Tumors
An open, non-randomized Phase Ib-II trial of dose-escalation and cohorts expansion to evaluate the safety, pharmacokinetic profile and initial efficacy of APG-115 alone or in combination with APG-2575 in the treatment of…
- Trial name
- NCT05701306
- Testing
- APG-115, APG-2575
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Ascentage Pharma Group Inc.
Neuroblastoma
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
- Trial name
- NCT04106219
- Testing
- LY3295668 Erbumine, Topotecan, Cyclophosphamide
- Where
- 17 sites in United States, Australia and 7 more
- Volunteers
- 71 people
- Sponsor
- Eli Lilly and Company
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Rituximab + High-Dose Methylprednisolone Debulking Prior to Venetoclax for CLL & SLL Patients
The purpose of the study is to investigate whether the combination of rituximab and high dose methylprednisolone can be given together, can reduce the amount of cancer cells that are present prior to starting venetoclax, and…
- Trial name
- NCT04981912
- Testing
- HDMP + rituximab as a means of debulking prior to initiating venetoclax.
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, San Diego
Adenosine Deaminase Severe Combined Immune Deficiency
Gene Therapy for Adenosine Deaminase Severe Combined Immune Deficiency Using Peripheral Blood and EFS ADA Vector
The aim of this study is to assess the safety and efficacy of autologous transplantation of hematopoietic stem cells (CD34+ cells) from mobilized peripheral blood (mPB) of ADA-deficient SCID infants and children following human…
- Trial name
- NCT05432310
- Testing
- A cryopreserved formulation of autologous mPB CD34+ hematopoietic stem and progenitor cells transduced ex vivo with the EFS-ADA lentiviral vector encoding the human ADA enzyme
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Los Angeles
HIV -1 Infection
Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (2)
The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS and VRC07-523-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in Mozambique and…
- Trial name
- ENABLE 2 (NCT07655141)
- Testing
- Broadly neutralizing antibody (bNAb) ePGT121v1-LS, Saline (0.9% NaCl), Broadly neutralizing antibody (bNAb) VRC07-523-LS
- Volunteers
- 73 people
- Sponsor
- Hospital Universitario 12 de Octubre
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
- Trial name
- PNeoVCA (NCT05269381)
- Testing
- Cyclophosphamide, Neoantigen Peptide Vaccine, Pembrolizumab
- Where
- United States
- Volunteers
- 138 people
- Sponsor
- Mayo Clinic
Neurofibromatosis Type 1
Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Tolerability of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas
This study in adolescent participants with NF1 who have inoperable PN is designed to evaluate the effect of a low fat meal on steady state selumetinib exposure; to assess the effect on GI tolerability when selumetinib is dosed…
- Trial name
- NCT05101148
- Testing
- Selumetinib
- Where
- 9 sites in United States, Poland and 2 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Angelman Syndrome
HALOS: A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Multiple Ascending Doses of ION582 in Participants With Angelman Syndrome
The purpose of this study is to evaluate the safety and tolerability of ascending doses of ION582 administered intrathecally in participants with Angelman syndrome.
- Trial name
- NCT05127226
- Testing
- ION582
- Where
- 11 sites in United States, Australia and 4 more
- Volunteers
- 71 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Primary Hyperoxaluria Type 1, PH1
Phase I Exploratory Study of YOLT-203 in Patients With Primary Hyperoxaluria Type 1 (PH1)
This is a single-arm, open-label, single-dose dose-escalation study. It aims to evaluate the safety and tolerability of YOLT-203 in Chinese patients with Primary Hyperoxaluria Type 1 (PH1), and to preliminarily assess the effect…
- Trial name
- NCT07776626
- Testing
- YOLT-203
- Where
- China
- Volunteers
- 9 people
- Sponsor
- YolTech Therapeutics Co., Ltd
Unresectable, Locally Advanced
A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in…
- Conditions
- Unresectable, Locally Advanced, Metastatic Cancers, Relapsed/Refractory Lymphomas
- Trial name
- DAHLIA (NCT06678659)
- Testing
- REC-1245
- Where
- 7 sites in United States, Canada
- Volunteers
- 170 people
- Sponsor
- Recursion Pharmaceuticals Inc.
Recurrent B Acute Lymphoblastic Leukemia, Recurrent Mixed Phenotype Acute Leukemia
Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia
This phase I trial studies the side effects and best dose of blinatumomab when given with nivolumab alone or nivolumab and ipilimumab in treating patients with poor-risk CD19+ precursor B-lymphoblastic leukemia that has come back…
- Conditions
- Recurrent B Acute Lymphoblastic Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Refractory B Acute Lymphoblastic Leukemia, Refractory Mixed Phenotype Acute Leukemia
- Trial name
- NCT02879695
- Testing
- Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration and Biopsy
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- National Cancer Institute (NCI)
HIV -1 Infection
Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life
The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in South Africa.
- Trial name
- ENABLE 1 (NCT07655128)
- Testing
- Broadly neutralizing antibody (bNAb) ePGT121v1-LS, Saline (0.9% NaCl)
- Volunteers
- 87 people
- Sponsor
- Hospital Universitario 12 de Octubre
Pediatric Hematologic Malignancies
Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies
This single arm pilot phase I study with safety run-in is designed to estimate the safety and efficacy of a familial mismatched or haploidentical hematopoietic stem cell transplantation (haplo-HSCT) using a novel graft…
- Trial name
- NCT05011422
- Testing
- Ex Vivo T-cell receptor alpha-beta and CD19+ Depletion using CliniMACs Plus
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Washington University School of Medicine
White Spot Lesions
Effect of the Use of Self-Assembling Peptides Versus Resin Infiltration on Post Orthodontic White Spot Lesions: A Randomized Clinical Trial
This study aim was to Investigate color change of post orthodontic white spot lesion after using self- assembling peptide (CURODONT) and compare the color change of post orthodontic white spot lesion between CURODONT and ICON
- Trial name
- WSL (NCT07773714)
- Testing
- Self-Assembling Peptide (Curodont Repair)
- Where
- Egypt
- Volunteers
- 42 people
- Sponsor
- Suez Canal University
Refractory Tumors, Malignant Tumors
Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents
Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment.
- Trial name
- NCT00412503
- Testing
- Topotecan, Temozolomide
- Where
- France
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Cancer, Pediatric Cancer
Study of Zanzalintinib in Children and Adolescents With Relapsed or Refractory Solid Tumors
The primary purpose of this study is to determine the pediatric maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and to evaluate the safety and tolerability of zanzalintinib.
- Trial name
- NCT07773454
- Testing
- Zanzalintinib
- Volunteers
- 18 people
- Sponsor
- Exelixis
Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter
Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury
This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.
- Trial name
- NCT03236064
- Testing
- Polyethylene Glycols
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- WellSpan Health
Acute Lymphocytic Leukemia Refractory, Lymphoma, Lymphoblastic
A Study of CTD402 in T-ALL/LBL Patients
The goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed/refractory T-ALL/LBL patients.
- Trial name
- TENACITY-01 (NCT07070219)
- Testing
- CTD402 CAR T Cell Injection
- Where
- 9 sites in United States, Australia
- Volunteers
- 118 people
- Sponsor
- Imviva Bio
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