Clinical trials: Phase 1b
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)
This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory…
- Trial name
- NCT06173518
- Testing
- AUTO1
- Where
- 14 sites in United States, Spain and 1 more
- Volunteers
- 30 people
- Sponsor
- Autolus Limited
Crohn Disease
Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease
This research study is investigating whether alpha beta T-cell depleted hematopoietic stem cell transplant (HSCT) can be an immune system replacement for Crohn disease patients and whether this is safe and effective for patients…
- Trial name
- NCT06986382
- Testing
- CliniMACS® TCR α/β Reagent Kit and CliniMACS® CD19 System, Prednisone/Methylprenisolone, Palifermin
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Stanford University
Chronic Graft-versus-host-disease
A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD
This study will be conducted to evaluate the safety, efficacy, and pharmacokinetics of axatilimab monotherapy in Chinese participants with recurrent or refractory active chronic graft-versus-host disease after systemic therapy.
- Trial name
- NCT06843408
- Testing
- INCA034176
- Where
- 9 sites in China
- Volunteers
- 32 people
- Sponsor
- Incyte Corporation
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
Ependymoma, Medulloblastoma
Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells.
- Conditions
- Ependymoma, Medulloblastoma, Glioblastoma, Primary Brain Tumor
- Trial name
- NCT05106296
- Testing
- Indoximod, Ibrutinib, Cyclophosphamide
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Theodore S. Johnson
Malaria,Falciparum
Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso
This clinical trial aims to learn about the safety and immunogenicity of the blood-stage malaria vaccine candidate SUM-101 in infants and children, paving the way for its incorporation into a multi-stage malaria vaccine.
- Trial name
- SUM-101 (NCT06618885)
- Testing
- SUM-101
- Where
- Burkina Faso
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- European Vaccine Initiative
Sarcoma
A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)
The main goal of this study is to test a new medicine, Risvutatug Rezetecan also called Ris-Rez. We want to see if this medicine can help people with certain types of cancer, whether its safe to use, how well people tolerate it…
- Trial name
- NCT07602777
- Testing
- Ris-Rez, G-CSF
- Where
- 13 sites in United States, Canada and 4 more
- Volunteers
- 64 people
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.
- Trial name
- NCT01797419
- Testing
- GS-5806
- Where
- 9 sites in Australia
- Sponsor
- Gilead Sciences
IDH1-mutant Glioma, IDH2-mutant Glioma
Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma
The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib.
- Trial name
- NCT06478212
- Testing
- Vorasidenib, Temozolomide (TMZ)
- Where
- 28 sites in United States, Austria and 9 more
- Volunteers
- 51 people
- Sponsor
- Institut de Recherches Internationales Servier
Meningitis, Cryptococcal, HIV Infections
Safety and Antifungal Activity of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Cryptococcal Meningitis
The purpose of this study is to examine the antifungal activity of recombinant interferon-gamma 1b (rIFN-gamma 1b) given with standard antifungal therapy.
- Trial name
- NCT00012467
- Testing
- Itraconazole, Flucytosine, Fluconazole
- Where
- 9 sites in United States, Peru
- Volunteers
- 60 people
- Sponsor
- InterMune
Dexmedetomidine, Mechanical Ventilation Complication
DOSE Trial of Opioid Sparing Effect
Multicenter, double blind randomized controlled trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children.
- Conditions
- Dexmedetomidine, Mechanical Ventilation Complication, Critically Ill
- Trial name
- DOSE (NCT03938857)
- Testing
- Fentanyl, Dexmedetomidine
- Where
- 19 sites in United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Fungal Infections
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.
- Trial name
- NCT01716234
- Testing
- Posaconazole 12 mg/kg/day BID, Posaconazole 18 mg/kg/day BID, Posaconazole 18 mg/kg/day TID
- Volunteers
- 142 people
- Sponsor
- Merck Sharp & Dohme LLC
Leukemia, Acute Myeloid Leukemia
A Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients With Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL Gene
A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) harbor rearrangements of the MLL gene, which are detected either by cytogenetic or fluorescent in situ hybridization evaluation at the…
- Conditions
- Leukemia, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Acute Leukemias
- Trial name
- NCT02141828
- Testing
- EPZ-5676
- Where
- 9 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Epizyme, Inc.
Acne Vulgaris
MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3
To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and…
- Trial name
- NCT04059523
- Testing
- S6G5T-3, Retin-A® 0.1% Cream
- Where
- 2 sites in United States
- Volunteers
- 62 people
- Sponsor
- Sol-Gel Technologies, Ltd.
Muscular Dystrophy, Duchenne
Modified Diet Trial: A Study of SMT C1100 in Paediatric Patients With DMD Who Follow a Balanced Diet
Placebo-controlled, multi-centre, randomized, double-blind dose escalation study. The aim is to evaluate the pharmacokinetics (PK) and safety of SMT C1100 in paediatric patients with Duchenne Muscular Dystrophy (DMD) who follow a…
- Trial name
- NCT02383511
- Testing
- SMT C1100
- Where
- 4 sites in United Kingdom
- Volunteers
- 12 people
- Sponsor
- Summit Therapeutics
Soft Tissue Sarcoma
A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma
The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma…
- Trial name
- ANNOUNCE 2 (NCT02659020)
- Testing
- Olaratumab, Gemcitabine, Docetaxel
- Where
- 48 sites in United States, Australia and 8 more
- Volunteers
- 310 people
- Sponsor
- Eli Lilly and Company
Melanoma, Solid Tumor
Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors
This is a subprotocol of Master Protocol DAY101-102 and is a Phase 1b/2, multi-center, open label subprotocol of participants ≥12 years of age, with recurrent or progressive solid tumors with alterations in the key proteins of…
- Conditions
- Melanoma, Solid Tumor, Pilocytic Astrocytoma, Non Small Cell Lung Cancer
- Trial name
- NCT07121829
- Testing
- Tovorafenib, Tovorafenib Drug: Pimasertib
- Where
- 10 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- Day One Biopharmaceuticals, Inc.
Relapsed Refractory B Precursor Acute Lymphoblastic Leukemia
Study of Blinatumomab in Japanese Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
This is an open-label, combined 2-part multicenter study to evaluate the efficacy, safety, and tolerability of blinatumomab in adult and pediatric Japanese patients with relapsed/refractory B-precursor ALL.
- Trial name
- NCT02412306
- Testing
- Blinatumomab
- Where
- 16 sites in Japan
- Volunteers
- 66 people
- Sponsor
- Amgen
Rhabdoid Tumor, Atypical Teratoid/Rhabdoid Tumor
Trial of Idasanutlin and Selinexor Therapy for Children With Progressive/Relapsed AT/RT or Extra-CNS Malignant Rhabdoid Tumors
iSTAR is an open-label, multi-center, phase 1b study of oral XPO1 inhibitor selinexor and oral MDM2 inhibitor idasanutlin in children with progressive or recurrent atypical teratoid/rhabdoid tumors (AT/RT), malignant rhabdoid…
- Conditions
- Rhabdoid Tumor, Atypical Teratoid/Rhabdoid Tumor, Atypical Teratoid/Rhabdoid Tumor of CNS, CNS Tumor
- Trial name
- NCT05952687
- Testing
- Idasanutlin, Selinexor
- Sponsor
- St. Jude Children's Research Hospital
Focal Seizures
A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Cannabidiol oral solution (CBD-OS) is approved in the US for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or Tuberous sclerosis complex (TSC) in patients 1 year of age and older.
- Trial name
- NCT07233239
- Testing
- CBD-OS
- Where
- 24 sites in United States
- Volunteers
- 100 people
- Sponsor
- Jazz Pharmaceuticals