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ClinicalTrials.gov public records Last synced Sep 13, 2026, 1:16 AM EDT

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Showing 1–23 of 23 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Leronlimab Clear all
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

NCT00110591
View directory record Official record
Conditions
HIV Infections
Interventions
PRO 140
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years to 50 Years · Male only
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2004 – 2008
U.S. locations
1
States / cities
Lincoln, Nebraska
Source: ClinicalTrials.gov public record
Updated Mar 13, 2023 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2 Interventional Results available

PRO 140 by IV Administration in Adults With HIV-1 Infection

NCT00613379
View directory record Official record
Conditions
HIV Infections
Interventions
PRO 140, Placebo
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
1
States / cities
Tarrytown, New York
Source: ClinicalTrials.gov public record
Updated Jul 14, 2016 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2 Interventional Results available

Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection

NCT00642707
View directory record Official record
Conditions
HIV -1 Infection, HIV Infections
Interventions
PRO 140 (humanized monoclonal antibody to CCR5), Placebo Comparator
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008
U.S. locations
1
States / cities
Tarrytown, New York
Source: ClinicalTrials.gov public record
Updated Jan 13, 2016 · Synced Sep 13, 2026, 1:16 AM EDT
Withdrawn Phase 2 Interventional

A Trial of Observed Long-acting, Anti-HIV Treatment With a Monoclonal CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Injection Drug Users With Viral Rebound and Documented Poor Adherence

NCT01272258
View directory record Official record
Conditions
HIV
Interventions
PRO 140, Placebo
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Feb 1, 2017 · Synced Sep 13, 2026, 1:16 AM EDT
Withdrawn Phase 2 Interventional

PRO 140 for Human Immunodeficiency Virus Infection

NCT02257788
View directory record Official record
Conditions
HIV
Interventions
PRO 140
Biological
Lead sponsor
Drexel University
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
7
States / cities
Stanford, California • Denver, Colorado • St Louis, Missouri + 3 more
Source: ClinicalTrials.gov public record
Updated Mar 8, 2017 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection

NCT02859961
View directory record Official record
Conditions
HIV
Interventions
PRO 140 (350 mg), PRO 140 (525 mg), PRO 140 (700 mg)
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
562 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
12
States / cities
La Mesa, California • Palm Springs, California • San Francisco, California + 9 more
Source: ClinicalTrials.gov public record
Updated Mar 3, 2026 · Synced Sep 13, 2026, 1:16 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC

NCT03838367
View directory record Official record
Conditions
Triple Negative Breast Neoplasms
Interventions
350 mg leronlimab, 525 mg leronlimab, 700 mg leronlimab, AUC 5 Carboplatin, Maximum Tolerated Dose (MTD) of leronlimab
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
2
States / cities
San Francisco, California • Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Sep 8, 2025 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140

NCT02483078
View directory record Official record
Conditions
HIV
Interventions
PRO 140, Placebo, Optimized Background Regimen
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
34
States / cities
Fountain Valley, California • Long Beach, California • Los Angeles, California + 24 more
Source: ClinicalTrials.gov public record
Updated Nov 2, 2022 · Synced Sep 13, 2026, 1:16 AM EDT
Terminated Phase 2 Interventional Results available

A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation

NCT02737306
View directory record Official record
Conditions
Graft Vs Host Disease
Interventions
PRO 140, Placebo
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
8
States / cities
Miami, Florida • Maywood, Illinois • Detroit, Michigan + 5 more
Source: ClinicalTrials.gov public record
Updated Mar 11, 2024 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2 Interventional Results available

Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19

NCT04678830
View directory record Official record
Conditions
Coronavirus Disease 2019
Interventions
Placebos, Leronlimab (700mg)
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
2
States / cities
Aventura, Florida • Gainesville, Georgia
Source: ClinicalTrials.gov public record
Updated Apr 10, 2024 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2 Interventional Results available

Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis

NCT04521114
View directory record Official record
Conditions
Nonalcoholic Steatohepatitis (NASH)
Interventions
Placebo, leronlimab 700 mg, leronlimab 350 mg
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
87 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
7
States / cities
Coronado, California • Maitland, Florida • Miami Lakes, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Feb 28, 2023 · Synced Sep 13, 2026, 1:16 AM EDT
Recruiting Phase 2 Interventional

Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease

NCT07553338
View directory record Official record
Conditions
Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, Alzheimer's Disease
Interventions
Leronlimab (700mg)
Drug
Lead sponsor
Weill Medical College of Cornell University
Other
Eligibility
50 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 21, 2026 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2 Interventional Results available

Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19

NCT04347239
View directory record Official record
Conditions
Coronavirus Disease 2019
Interventions
Placebo, Leronlimab (700mg)
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
484 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
18
States / cities
Alexander City, Alabama • Fullerton, California • Los Angeles, California + 14 more
Source: ClinicalTrials.gov public record
Updated Oct 14, 2025 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2 Interventional Results available

Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors

NCT04504942
View directory record Official record
Conditions
Solid Tumor, Adult
Interventions
Leronlimab
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Jan 22, 2026 · Synced Sep 13, 2026, 1:16 AM EDT
Active, not recruiting Phase 2 Interventional

CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen

NCT06699836
View directory record Official record
Conditions
Metastatic Colorectal Cancer (mCRC)
Interventions
350 mg leronlimab, 700 mg leronlimab, 200 mg pembrolizumab
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
7
States / cities
Irvine, California • San Francisco, California • Washington D.C., District of Columbia + 4 more
Source: ClinicalTrials.gov public record
Updated Sep 8, 2026 · Synced Sep 13, 2026, 1:16 AM EDT
Withdrawn Phase 2 Interventional

PRO 140 for Human Immunodeficiency Virus

NCT02438345
View directory record Official record
Conditions
HIV
Interventions
PRO 140
Biological
Lead sponsor
Drexel University
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
Phildadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Mar 2, 2017 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2 Interventional Results available

Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19

NCT04343651
View directory record Official record
Conditions
Coronavirus Disease 2019
Interventions
Placebo, Leronlimab (700mg)
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years to 99 Years
Enrollment
86 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
12
States / cities
Los Angeles, California • Palm Springs, California • Rancho Mirage, California + 9 more
Source: ClinicalTrials.gov public record
Updated Jan 3, 2023 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2 Interventional Results available

Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection

NCT02175680
View directory record Official record
Conditions
HIV, Human Immunodeficiency Virus
Interventions
PRO 140, Historical data
Drug · Other
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Apr 13, 2023 · Synced Sep 13, 2026, 1:16 AM EDT
Available No phase listed Expanded access

An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC)

NCT07536815
View directory record Official record
Conditions
TNBC, TNBC - Triple-Negative Breast Cancer, TNBC, Triple Negative Breast Cancer
Interventions
leronlimab (PRO 140)
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
U.S. locations
1
States / cities
Salem, Oregon
Source: ClinicalTrials.gov public record
Updated Apr 26, 2026 · Synced Sep 13, 2026, 1:16 AM EDT
Terminated Phase 2 Interventional Results available

An Extension of Protocol PRO 140_CD01 Study

NCT02355184
View directory record Official record
Conditions
HIV, Human Immunodeficiency Virus
Interventions
PRO 140 350mg weekly subcutaneous (SC) injection.
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2022
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Oct 6, 2025 · Synced Sep 13, 2026, 1:16 AM EDT
Terminated Phase 2Phase 3 Interventional Results available

An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study

NCT05271370
View directory record Official record
Conditions
HIV-1-infection
Interventions
PRO 140 350, PRO 140 525, PRO 140 700
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Oct 29, 2025 · Synced Sep 13, 2026, 1:16 AM EDT
Completed Phase 2Phase 3 Interventional Results available

PRO 140 in Treatment-Experienced HIV-1 Subjects

NCT03902522
View directory record Official record
Conditions
HIV-1-infection
Interventions
PRO 140
Drug
Lead sponsor
CytoDyn, Inc.
Industry
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
17
States / cities
Palm Springs, California • San Francisco, California • New Haven, Connecticut + 11 more
Source: ClinicalTrials.gov public record
Updated Sep 15, 2025 · Synced Sep 13, 2026, 1:16 AM EDT