Clinical trials: Neutralizing Antibody
Covid19
Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidates VBI-2902a and VBI-2905a
VBI-2902a and VBI-2905a are investigational vaccine candidates that use enveloped virus-like particle (eVLP) expression of a modified version of the SARS-CoV-2 spike (S) glycoprotein and are designed to induce neutralizing…
- Trial name
- NCT04773665
- Testing
- VBI-2902a, VBI-2905a
- Where
- 4 sites in Canada
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
HIV Infections
Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV was well-controlled with HIV medicines.
- Trial name
- NCT02463227
- Testing
- VRC01
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1
Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults
Background: The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated.
- Trial name
- NCT02840474
- Testing
- VRC-HIVMAB080-00-AB, VRC-HIVMAB075-00-AB
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 16 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lymphoma, Metastatic Malignant Solid Neoplasm
Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma
This phase I trial studies the best dose and side effects of trigriluzole in combination with nivolumab and pembrolizumab in treating patients with solid malignancies or lymphoma that has spread to other places in the body or…
- Conditions
- Lymphoma, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Renal Cell Cancer
- Trial name
- NCT03229278
- Testing
- Enzyme Inhibitor Therapy, Laboratory Biomarker Analysis, Nivolumab
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Rutgers, The State University of New Jersey
Prostate Cancer
IGF Inhibition With Xentuzumab Prior to Radical Prostatectomy
The WINGMEN trial aims to understand how a hormone-like protein called insulin-like growth factor (IGF) helps prostate cancers grow and become aggressive.
- Trial name
- WINGMEN (NCT05110495)
- Testing
- Xentuzumab
- Where
- United Kingdom
- Volunteers
- 27 people
- Sponsor
- University of Oxford
Diabetes Mellitus, Type 1
Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 [Ala-Ala],teplizumab, MGA031) is a humanized antibody that is commonly used to prevent organ rejection.
- Trial name
- AbATE (NCT00129259)
- Testing
- Anti-CD3 mAb, Diabetes Standard of Care Treatment, Iron supplementation
- Where
- 7 sites in United States
- Volunteers
- 83 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men
The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.
- Trial name
- NCT00865566
- Testing
- DNA plasmid vaccine, Recombinant adenoviral serotype 5 (rAD5) vector vaccine
- Where
- 22 sites in United States
- Volunteers
- 2,504 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults
Background: HIV causes AIDS, a serious disease that can lead to fatal infections. HIV infection can be controlled but not cured, nor is there a vaccine to prevent it.
- Trial name
- NCT05627258
- Testing
- VRC-HIVMAB0115-00-AB
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection
This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV…
- Trial name
- NCT02591420
- Testing
- VRC01, Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
- Where
- 5 sites in Kenya, Tanzania and 2 more
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
- Trial name
- NCT02256631
- Testing
- VRC01, VRC01LS, VRC07-523LS
- Where
- 14 sites in United States, Puerto Rico and 2 more
- Volunteers
- 83 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Metastatic Pancreatic Cancer
Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
The purpose of this study is to evaluate the safety and clinical activity of plerixafor in combination with cemiplimab in patients with metastatic pancreatic cancer.
- Trial name
- NCT04177810
- Testing
- Cemiplimab, Plerixafor
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Trigeminal Neuralgia, Glossopharyngeal Neuralgia
Anti-CGRP for Inflammation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia
The investigators will treat patients (targeting enrollment of n=20) who suffer from trigeminal or glossopharyngeal nerve pain in the context of painful small fiber neuropathy.
- Trial name
- NCT04158752
- Testing
- Galcanezumab
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Duke University
Respiratory Syncytial Virus
Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults
Background: Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two.
- Trial name
- NCT03049488
- Testing
- VRC-RSVRGP084-00-VP, Aluminum Hydroxide Suspension
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV/AIDS
Combinatorial Therapy to Induce an HIV Remission
Combination approaches will almost certainly be required to generate durable control of HIV in the absence of antiretroviral therapy (a "remission").
- Trial name
- NCT04357821
- Testing
- Combination Intervention
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of California, San Francisco
HIV
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs.
- Trial name
- VRC 611 (NCT04408963)
- Testing
- VRC-HIVMAB0102-00-AB
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Covid19
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered intravenously as a single dose in participants with mild to moderate COVID-19
- Trial name
- NCT04551898
- Testing
- BGB-DXP593
- Where
- 18 sites in United States, Brazil and 2 more
- Volunteers
- 181 people
- Sponsor
- BeiGene
HIV-1-infection
Pharmacokinetics and Safety of SAR441236
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of SAR441236, a tri-specific broadly neutralizing antibody against the human immunodeficiency virus (HIV).
- Trial name
- NCT03705169
- Testing
- SAR441236
- Where
- 23 sites in United States
- Volunteers
- 52 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Adult Immune Response
Phase I Study to Evaluate a Human Monoclonal Antibody (MAb) 10E8VLS Administered Alone or Concurrently With MAb VRC07-523LS Via Subcutaneous Injection in Healthy Adults
Background: Human immunodeficiency virus (HIV) infection is a serious disease. There is no cure or vaccine to prevent infection. Using antibodies might be a good way to treat or prevent HIV.
- Trial name
- NCT03565315
- Testing
- VRC-HIVMAB095-00-AB (10E8VLS), VRC-HIVMAB075-00-AB (VRC07-523LS)
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Immunodeficiency Virus
3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals
The proposed study is a phase 1, open label, single arm study to evaluate the safety, pharmacokinetics and antiviral activity of single intravenous infusions of 3BNC117-LS and 10-1074-LS, each monoclonal antibody (mAb) dosed at…
- Trial name
- NCT04250636
- Testing
- 3BNC117-LS, 10-1074-LS
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Rockefeller University
HIV Infections
A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults
This study is to evaluate antiviral activity, efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment naive adults.
- Trial name
- NCT04871113
- Testing
- GSK3810109A, Dolutegravir+lamivudine SOC regimen
- Where
- 24 sites in United States, Argentina and 4 more
- Volunteers
- 62 people
- Sponsor
- ViiV Healthcare