Clinical trials: Phase 1
Danon Disease
Gene Therapy for Male Patients With Danon Disease (DD) Using RP-A501; AAV9.LAMP2B
This is a non-randomized open-label Phase 1 study to evaluate the safety and toxicity of gene therapy using a recombinant adeno-associated virus serotype 9 (AAV9) containing the human lysosome-associated membrane protein 2…
- Trial name
- NCT03882437
- Testing
- RP-A501
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Pediatric Malignant Solid Tumor and Epithelioid Sarcoma
A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.
This is a multicenter, open-label, uncontrolled Phase I/II study to evaluate the efficacy, safety, and pharmacokinetics of ONO-4538HSC in pediatric patients with malignant solid tumors and in patients with epithelioid sarcoma…
- Trial name
- NCT07734116
- Testing
- ONO-4538HSC
- Where
- 15 sites in Japan
- Volunteers
- 50 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
High Risk Neuroblastoma
Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma
This clinical trial investigates the safety, side effects, and effectiveness of combining an immunotherapy drug called dinutuximab-beta with standard induction chemotherapy for patients newly diagnosed with high-risk…
- Trial name
- NCT07688252
- Testing
- Dinutuximab Beta, Induction chemotherapy
- Where
- 2 sites in Taiwan
- Volunteers
- 30 people
- Sponsor
- Chang Gung Memorial Hospital
Acute Leukemia of Ambiguous Lineage in Relapse, Acute Myeloid Leukemia, in Relapse
Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
The purpose of this study is to test the safety and determine the best dose of venetoclax and selinexor when given with chemotherapy drugs in treating pediatric and young adult patients with acute myeloid leukemia (AML) or acute…
- Conditions
- Acute Leukemia of Ambiguous Lineage in Relapse, Acute Myeloid Leukemia, in Relapse, Refractory Acute Leukemia of Ambiguous Lineage, Refractory Acute Myeloid Leukemia
- Trial name
- NCT04898894
- Testing
- Venetoclax, Selinexor, Cytarabine
- Where
- 8 sites in United States
- Volunteers
- 37 people
- Sponsor
- St. Jude Children's Research Hospital
Systemic Lupus Erythematosus, Lupus Nephritis
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
- Trial name
- NCT06121297
- Testing
- CABA-201
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 28 people
- Sponsor
- Cabaletta Bio
Mature B-Cell Non-Hodgkin Lymphoma
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric…
- Trial name
- iMATRIX GLO (NCT05533775)
- Testing
- Obinutuzumab, Glofitamab, Rituximab
- Where
- 30 sites in United States, Australia and 11 more
- Volunteers
- 65 people
- Sponsor
- Hoffmann-La Roche
Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
The purpose of this study is to find out whether CD371-YSNVZ-IL18 CAR T cells are safe, and to look for the highest dose of CD371-YSNVZ-IL18 CAR T cells that cause few or mild side effects in participants.
- Conditions
- Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse
- Trial name
- NCT06017258
- Testing
- CD371-specific/YSNVz/I-18 CAR T cells
- Where
- 7 sites in United States
- Volunteers
- 15 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Metastatic Breast Cancer, HER2-negative Breast Cancer
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
- Conditions
- Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- TRACY-1 (NCT06590857)
- Testing
- RYZ101, Standard of Care Endocrine Therapy
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 64 people
- Sponsor
- RayzeBio, Inc.
Metastatic Melanoma, Stage III Cutaneous Melanoma AJCC v7
Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma
This pilot phase I trial studies the side effects and best dose of genetically modified T-cells followed by aldesleukin in treating patients with stage III-IV melanoma.
- Conditions
- Metastatic Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7
- Trial name
- NCT01955460
- Testing
- Aldesleukin, Cyclophosphamide, Fludarabine Phosphate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- M.D. Anderson Cancer Center
Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia, Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia
A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia
The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.
- Trial name
- NCT07134088
- Testing
- Blinatumomab
- Where
- 5 sites in United States, Japan
- Volunteers
- 104 people
- Sponsor
- Amgen
Menkes Disease
NORTHERA (DROXIDOPA) for Dysautonomia in Pediatric Survivors of Menkes Disease
This clinical trial will evaluate the safety, tolerability, dosing, and efficacy of Northera (Droxidopa) in children with Menkes disease aged 7 to 17 years who survived the major neurodegenerative and neurocognitive effects of…
- Trial name
- NCT07398508
- Testing
- Droxidopa Oral Product
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Stephen G. Kaler
Prematurity Complications
Gut Permeability and Microbiome in Preterm Infants
NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth with mortality as high as 30-50%.
- Trial name
- NCT07667049
- Testing
- measurement of intestinal permeability
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Maryland, Baltimore
Acute Myeloid Leukemia
Total Marrow and Lymphoid Irradiation Before Donor Transplant and Cyclophosphamide in Treating Patients With Acute Myeloid Leukemia
This pilot phase I trial studies the side effects of total bone marrow and lymphoid irradiation and how well it works with cyclophosphamide in treating patients with acute myeloid leukemia.
- Trial name
- NCT03467386
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Filgrastim
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- City of Hope Medical Center
Muscular Dystrophy, Facioscapulohumeral
Study of SRP-1001 in Adult and Adolescent Participants With Facioscapulohumeral Muscular Dystrophy Type 1
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of SRP-1001 in participants with facioscapulohumeral muscular dystrophy Type 1 (FSHD1).
- Trial name
- NCT06131983
- Testing
- SRP-1001 for Injection
- Where
- 16 sites in Australia, Canada and 5 more
- Volunteers
- 60 people
- Sponsor
- Sarepta Therapeutics, Inc.
Early Onset Sepsis, Preterm Neonates
Optimizing PreTerm Infant Ampicillin Dosing
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safely receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours).
- Conditions
- Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin
- Trial name
- OPTI-Amp (NCT07610486)
- Testing
- Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Acute Myeloid Leukemia
A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment.
- Trial name
- NCT07306832
- Testing
- Pivekimab Sunirine
- Where
- 14 sites in United States, Australia and 5 more
- Volunteers
- 18 people
- Sponsor
- AbbVie
B Cell Lymphoma, Chronic Lymphocytic Leukemia
CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, ALL & CLL
Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma, Acute Lymphocytic Leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "Lymphoma" or "Leukemia").
- Conditions
- B Cell Lymphoma, Chronic Lymphocytic Leukemia, Acute Lymphocytic Leukemia
- Trial name
- CRETI-NH (NCT00586391)
- Testing
- CD19CAR-28-zeta T cells, Ipilimumab
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Baylor College of Medicine
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
Advanced Solid Tumors With MTAP Deletion
A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors（G-MAP 101）
This is a multicenter, single-arm, open-label, dose-escalation, dose-expansion study to evaluate the safety, tolerability, PK/PD, and preliminary anti-tumor activity of GH56 Capsule in subjects with advanced solid tumors who have…
- Trial name
- NCT06796699
- Testing
- GH56 Capsule
- Where
- 25 sites in China
- Volunteers
- 200 people
- Sponsor
- Suzhou Genhouse Bio Co., Ltd.
Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)
Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT
Subjects are having a bone marrow or SCT for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called non- Hodgkin's Lymphoma.
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Non Hodgkin's Lymphoma
- Trial name
- MULTIPRAT (NCT00840853)
- Testing
- CD19CAR/virus specific T cells, Benadryl and Tylenol
- Where
- 2 sites in United States
- Volunteers
- 68 people
- Sponsor
- Baylor College of Medicine
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