Clinical trials: Immunological Mechanisms
Vaccination Reaction
Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine
The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants.
- Trial name
- TETRALITE-Ib (NCT06294262)
- Testing
- TETRALITE
- Where
- Belgium
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- LiteVax BV
Dengue, Dengue Fever
Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine
The aim of the study was to evaluate a compressed dosing schedule and the immunologic effects of co-administration of a CYD dengue vaccine with a licensed flavivirus (FV) with Japanese encephalitis (JE) vaccine.
- Conditions
- Dengue, Dengue Fever, Dengue Hemorrhagic Fever
- Trial name
- NCT01943825
- Testing
- CYD Dengue Vaccine, Japanese Encephalitis Vaccine
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Breast Cancer
Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Before Surgery in Treating Women With Large Breast Cancer Tumors
The purpose of this randomized Phase III study is to determine whether preoperative focused microwave heat treatment and chemotherapy combined are more effective than preoperative chemotherapy alone in the treatment of large…
- Trial name
- Medifocus301 (NCT01204801)
- Testing
- Focused Microwave Thermotherapy, Chemotherapy (control)
- Where
- 2 sites in United States, Canada
- Volunteers
- 238 people
- Sponsor
- Medifocus, Inc.
Astrocytoma, Grade IV, Giant Cell Glioblastoma
Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM
This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme, Cyclophosphamide
- Trial name
- CYNK001GBM01 (NCT04489420)
- Testing
- CYNK001-IV, CYNK001-IT
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Celularity Incorporated
Hereditary Angioedema (HAE)
Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
- Trial name
- NCT02045264
- Testing
- Icatibant (30 mg)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shire
Acute Ischemic Stroke
Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor
Single-chain urokinase-type plasminogen activator (pro-urokinase) is a highly effective thrombolytic drug. At pharmacologic concentrations however, pro-urokinase is converted to urokinase - a non specific thrombolytic, limiting…
- Trial name
- NCT01694381
- Testing
- M5, C1-inhibitor
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- TSI, LLC
Solid Tumor, Adult, Solid Tumor Cancer
Study of DF6215 in Patients With Advanced Solid Tumors
A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 Monotherapy and in Combination Therapy in Patients with Advanced…
- Trial name
- NCT06108479
- Testing
- DF6215, pembrolizumab, KEYTRUDA®
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 35 people
- Sponsor
- Dragonfly Therapeutics
HIV Infections, Metabolism, Lipids
An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects
1. In order to obtain further insight as to how NVP affects HDL metabolism, the in vivo kinetics of the HDL apolipoprotein, Apo A-1, before and 6 weeks after initiation of NVP containing treatment were evaluated.
- Trial name
- NCT00144261
- Testing
- nevirapine
- Where
- 3 sites in Netherlands, United Kingdom
- Volunteers
- 15 people
- Sponsor
- Boehringer Ingelheim
Rectal Cancer
Tecemotide (L-BLP25) in Rectal Cancer
The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagnosed rectal cancer who are…
- Trial name
- SPRINT (NCT01507103)
- Testing
- Tecemotide (L-BLP25), cyclophosphamide (CPA), Chemoradiotherapy
- Where
- Netherlands
- Volunteers
- 124 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Diabetic Macular Edema
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis®…
- Trial name
- OXEYE (NCT05697809)
- Testing
- OXU-001, Semi-automated suprachoroidal illuminated microcatheter, Ozurdex® Ophthalmic Intravitreal Implant
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 3 people
- Sponsor
- Oxular Limited
HIV Infections
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.
- Trial name
- NCT00504452
- Testing
- KP-1461
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 27 people
- Sponsor
- Koronis Pharmaceuticals.
Leukemia, Leukemia, Myeloid
Natural Killer Cell (CYNK-001) Infusions in Adults with AML
This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Neoplasms by Histologic Type
- Trial name
- CYNK001AML01 (NCT04310592)
- Testing
- CYNK-001
- Where
- 10 sites in United States
- Volunteers
- 27 people
- Sponsor
- Celularity Incorporated
Hepatitis C
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2…
- Trial name
- NCT01808248
- Testing
- SOF, PEG, RBV
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences
Solid Tumor, Non-Small Cell Lung Cancer
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in…
- Conditions
- Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma
- Trial name
- NCT04198766
- Testing
- INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg, pembrolizumab 400 mg
- Where
- 42 sites in United States, Singapore and 2 more
- Volunteers
- 340 people
- Sponsor
- Inhibrx Biosciences, Inc
Colorectal Cancer
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine…
- Trial name
- NCT00838578
- Testing
- KRN330, Irinotecan
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Kyowa Kirin Co., Ltd.