Clinical trials: Phase 1
Mucopolysaccharidosis III-B
An Open-label Phase I/II Study of JR-446 in Mucopolysaccharidosis Type IIIB
A Phase I/ II, open-label study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of MPS IIIB patients.
- Trial name
- NCT06488924
- Testing
- JR-446
- Where
- 4 sites in Japan
- Volunteers
- 10 people
- Sponsor
- JCR Pharmaceuticals Co., Ltd.
Malaria
L9LS MAb in Malian Infants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.
- Trial name
- NCT06461026
- Testing
- L9LS, R21/Matrix-MTM
- Where
- 3 sites in Mali
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Recurrent Breast Carcinoma, Recurrent Fallopian Tube Carcinoma
Mirvetuximab Soravtansine and Gemcitabine Hydrochloride in Treating Patients With FRalpha-Positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial, or Triple Negative Breast Cancer
This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and gemcitabine hydrochloride in treating patients with folate receptor (FR) alpha-positive ovarian, primary peritoneal, fallopian tube…
- Conditions
- Recurrent Breast Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Trial name
- NCT02996825
- Testing
- Gemcitabine, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 44 people
- Sponsor
- City of Hope Medical Center
Germ Cell Cancer
Phase 1/2 Study Of PARP Inhibition With Olaparib To Enhance The Efficacy Of High-Dose Chemotherapy In Refractory And Relapsed Germ Cell Tumors
The goal of this clinical research study is to find the highest safe dose of olaparib that can be combined with chemotherapy drugs and stem cell transplantation to treat patients with relapsed and refractory germ cell cancer.
- Trial name
- NCT07850973
- Testing
- Olaparib, Gemcitabine, Docetaxel
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- M.D. Anderson Cancer Center
Philadelphia Chromosome Positive CML, Accelerated Phase Chronic Myelogenous Leukemia
Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia
This is a Phase 1-2, multicenter, international, single-arm, open-label study designed to identify a recommended dose of bosutinib administered orally once daily in pediatric patients with newly diagnosed chronic phase Ph+ CML…
- Conditions
- Philadelphia Chromosome Positive CML, Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Chronic Phase Chronic Myelogenous Leukemia
- Trial name
- NCT04258943
- Testing
- Bosutinib
- Where
- 59 sites in United States, France and 6 more
- Volunteers
- 60 people
- Sponsor
- Children's Oncology Group
Osteosarcomas, Bone Cancer
Phase I/II Trial of Dinutuximab Beta in Combination With Irinotecan and Rapamycin in Pediatric, Adolescents and Adult Patients With Relapsed/Refractory Bone Tumors.
Osteosarcomas, like other primitive bone tumors, remain hard-to-treat malignancies, especially after failure of first-line treatments.
- Conditions
- Osteosarcomas, Bone Cancer, Ewing Sarcomas
- Trial name
- BONE DINIRRA (NCT07853105)
- Testing
- Dinutuximab beta, Sirolimus and Irinotecan
- Where
- 12 sites in France
- Volunteers
- 89 people
- Sponsor
- University Hospital, Strasbourg, France
High-Grade Glioma
Novel Targeted Radiotherapy in Pediatric Patients With Inoperable Relapsed or Refractory HGG
The purpose of this dose finding study is to evaluate the safety and efficacy of 2 different dose levels of CLR 131 in children, adolescents and young adults with relapsed or refractory high-grade glioma (HGG).
- Trial name
- NCT05610891
- Testing
- CLR 131
- Where
- 8 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Cellectar Biosciences, Inc.
Hodgkin Disease, Lymphoma
Administration of T Lymphocytes for Prevention of Relapse of Lymphomas
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells.
- Conditions
- Hodgkin Disease, Lymphoma, Lymphoma, Non-Hodgkin, Immune System Diseases
- Trial name
- NCT02663297
- Testing
- ATLCAR.CD30 cells
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Wilson Disease, Wilson's Disease
A Study of the Safety and Efficacy of Prime Editing (PM577) in Participants With Wilson Disease (WD)
The purpose of this study is to evaluate the safety, tolerability, biological activity, and initial efficacy of PM577a, an investigational Prime Editing therapy, in adults and adolescents with Wilson disease (WD).
- Conditions
- Wilson Disease, Wilson's Disease, Wilsons Disease
- Trial name
- PM577a (NCT07748403)
- Testing
- PM577a
- Where
- 4 sites in United States, New Zealand
- Volunteers
- 42 people
- Sponsor
- Prime Medicine, Inc.
Biliary Atresia
Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG treatment administered to infants after…
- Trial name
- PRIME (NCT01854827)
- Testing
- Intravenous immunoglobulin (IVIG)
- Where
- 7 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Low-grade Glioma
A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours
The purpose of this study is to evaluate safety and the way the body absorbs, distributes and gets rid of the study drug tovorafenib in the body in Japanese children, adolescents and young adults with specific brain tumours.
- Trial name
- NCT07441707
- Testing
- Tovorafenib
- Where
- 6 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Ipsen
Stargardt Disease
A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)
The purpose of the 039-101 study is to evaluate the safety and tolerability of a single subretinal injection of AAVB-039 in participants with Stargardt disease secondary to a biallelic mutation of the ABCA4 gene.
- Trial name
- CELESTE (NCT07161544)
- Testing
- AAVB-039
- Where
- 11 sites in United States, Norway and 1 more
- Volunteers
- 75 people
- Sponsor
- AAVantgarde Bio Srl
Childhood Posterior Fossa Ependymoma
Testing Safe Doses of Anti-Cancer Medicines, 5-Flurouracil (5-FU) and Tretinoin (ATRA), Added to the Usual Cancer Treatment of Ependymoma
This phase I/II trial tests the safety, side effects best dose and how well giving fluorouracil and tretinoin along with standard of care radiation therapy works for the treatment of high risk posterior fossa ependymoma that has…
- Trial name
- NCT07848568
- Testing
- Biospecimen Collection, Echocardiography Test, Fluorouracil
- Volunteers
- 70 people
- Sponsor
- Children's Oncology Group
Neuroblastoma, Neuroblastoma Recurrent
Anti-GD2 CAR T Cells in Pediatric Patients Affected by High Risk and/or Relapsed/Refractory Neuroblastoma or Other GD2-positive Solid Tumors
The purpose of this study is to test the safety and efficacy of GD2-CART01, a CAR T cell treatment targeting GD2 in paediatric or young adult patients with High Risk and/or relapsed/refractory Neuroblastoma.
- Conditions
- Neuroblastoma, Neuroblastoma Recurrent, GD2-positive Solid Tumors, Osteosarcoma
- Trial name
- NCT03373097
- Testing
- GD2-CART01
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- Bambino Gesù Hospital and Research Institute
Acute Myeloid Leukemia
Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant
This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-redirected chimeric antigen receptor engineered T-cells (CD4CAR) in subjects with relapsed or refractory AML.
- Trial name
- NCT06197672
- Testing
- CD4CAR
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Huda Salman
Recurrent Anaplastic Large Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma
Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas
This phase I/II trial studies the side effects and best dose of modified umbilical cord blood immune cells (natural killer [NK] cells) combined with the antibody AFM13 (AFM13-NK) and AFM13 alone in treating patients with CD30…
- Conditions
- Recurrent Anaplastic Large Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Classic Hodgkin Lymphoma, Recurrent Mycosis Fungoides
- Trial name
- NCT04074746
- Testing
- Anti-CD30/CD16A Monoclonal Antibody AFM13, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- M.D. Anderson Cancer Center
Osteosarcoma, Pulmonary Recurrence of Osteosarcoma
Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma
This study aims to determine the safety and tolerability of combined Atezolizumab, stereotactic body radiation therapy (SBRT), and surgical resection of pulmonary metastases in patients with pulmonary recurrence of osteosarcoma
- Trial name
- AflacST2301 (NCT06492954)
- Testing
- Surgical Resection, Stereotactic Body Radiation Therapy (SBRT), Atezolizumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Emory University
Brain Tumor, Pediatric, Medulloblastoma, Childhood
GD2-CAR T Cells for Pediatric Brain Tumours
The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed/refractory…
- Conditions
- Brain Tumor, Pediatric, Medulloblastoma, Childhood, Embryonal Tumor, High Grade Glioma
- Trial name
- NCT05298995
- Testing
- GD2-CART01 (iC9-GD2-CAR T-cells)
- Where
- Italy
- Volunteers
- 54 people
- Sponsor
- Bambino Gesù Hospital and Research Institute
Brain Tumor
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
- Trial name
- NCT04085887
- Testing
- Panitumumab-IRDye800, Pinpoint-IR9000 endoscopic/handheld device, Explorer Air camera
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
Recurrent Medulloblastoma
RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB)
The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in pediatric patients with recurrent/progressive Medulloblastoma (MB)
- Trial name
- PNOC020 rMB (NCT07492316)
- Testing
- Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Florida
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