12 completed, 5 terminated, 3 withdrawn, 2 no longer available. 21 Phase 2, 7 Phase 3, 3 Phase 1.
Follow leronlimab: new trials by email Literature Review of leronlimab trials Research Report on leronlimab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| CCR5 Targeting Leronlimab in Combination With Hepatic Arterial Infusion Floxuridine and Systemic Therapy for the Treatment of Colorectal Cancer Liver Metastases, CHAMP Trial Biopsy Procedure, Biospecimen Collection, Computed Tomography - Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver | Phase 1 | Not yet recruiting | City of Hope Medical Center | 36 | 2027-05-06 | 2026-09-25 |
| Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease Leronlimab (700mg) - Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, Alzheimer's Disease | Phase 2 | Recruiting | Weill Medical College of Cornell University | 20 | 2026-04-30 | 2026-05-22 |
| CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen 350 mg leronlimab, 700 mg leronlimab, 200 mg pembrolizumab - Metastatic Colorectal Cancer (mCRC) | Phase 2 | Active not recruiting | CytoDyn, Inc. | 66 | 2025-06-16 | 2026-09-09 |
| Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation Leronlimab, Placebo - COVID-19 Pneumonia | Phase 3 | Suspended | Hospital Israelita Albert Einstein | 316 | 2021-10-23 | 2022-04-15 |
| Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia Leronlimab, Placebo - COVID-19 Pneumonia | Phase 3 | Suspended | Hospital Israelita Albert Einstein | 612 | 2021-09-09 | 2022-04-15 |
| Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19 Placebos, Leronlimab (700mg) - Coronavirus Disease 2019 | Phase 2 | Completed | CytoDyn, Inc. | 56 | 2021-03-01 | 2024-04-11 |
| Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis Placebo, leronlimab 700 mg, leronlimab 350 mg - Nonalcoholic Steatohepatitis (NASH) | Phase 2 | Completed | CytoDyn, Inc. | 87 | 2020-12-01 | 2023-03-01 |
| Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors Leronlimab - Solid Tumor, Adult | Phase 2 | Completed | CytoDyn, Inc. | 16 | 2020-05-01 | 2026-01-23 |
| Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19 Placebo, Leronlimab (700mg) - Coronavirus Disease 2019 | Phase 2 | Completed | CytoDyn, Inc. | 484 | 2020-04-16 | 2025-10-15 |
| Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19 Placebo, Leronlimab (700mg) - Coronavirus Disease 2019 | Phase 2 | Completed | CytoDyn, Inc. | 86 | 2020-04-01 | 2023-01-04 |
| Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC 350 mg leronlimab, 525 mg leronlimab, 700 mg leronlimab - Triple Negative Breast Neoplasms | Phase 1 / Phase 2 | Terminated | CytoDyn, Inc. | 10 | 2019-04-22 | 2025-09-09 |
| PRO 140 in Treatment-Experienced HIV-1 Subjects PRO 140 - HIV-1-infection | Phase 2 / Phase 3 | Completed | CytoDyn, Inc. | 6 | 2018-06-25 | 2025-09-16 |
| An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study PRO 140 350, PRO 140 525, PRO 140 700 - HIV-1-infection | Phase 2 / Phase 3 | Terminated | CytoDyn, Inc. | 56 | 2017-08-29 | 2025-10-30 |
| A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation PRO 140, Placebo - Graft Vs Host Disease | Phase 2 | Terminated | CytoDyn, Inc. | 11 | 2017-05-14 | 2024-03-12 |
| Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection PRO 140 (350 mg), PRO 140 (525 mg), PRO 140 (700 mg) - HIV | Phase 2 / Phase 3 | Completed | CytoDyn, Inc. | 562 | 2016-12-07 | 2026-03-04 |
| An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study PRO 140 - Human Immunodeficiency Virus (HIV) | Phase 2 / Phase 3 | Terminated | CytoDyn, Inc. | 43 | 2016-11-03 | 2025-11-12 |
| Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140 PRO 140, Placebo, Optimized Background Regimen - HIV | Phase 2 / Phase 3 | Completed | CytoDyn, Inc. | 52 | 2015-10-01 | 2022-11-03 |
| An Extension of Protocol PRO 140_CD01 Study PRO 140 350mg weekly subcutaneous (SC) injection. - HIV, Human Immunodeficiency Virus | Phase 2 | Terminated | CytoDyn, Inc. | 20 | 2014-11-18 | 2025-10-07 |
| PRO 140 for Human Immunodeficiency Virus Infection PRO 140 - HIV | Phase 2 | Withdrawn | Drexel University | 2014-09-01 | 2017-03-09 | |
| Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection PRO 140, Historical data - HIV, Human Immunodeficiency Virus | Phase 2 | Completed | CytoDyn, Inc. | 43 | 2014-04-16 | 2023-04-14 |
Showing 20 of 28. Sign in to see all of them.
COVID-19 (5) · Acquired Immunodeficiency Syndrome (3) · HIV Infections (3) · Triple Negative Breast Neoplasms (3) · Colorectal Neoplasms (2) · Pneumonia (2) · Alzheimer Disease (1) · Cognitive Dysfunction (1) · Graft vs Host Disease (1) · Non-alcoholic Fatty Liver Disease (1)
CytoDyn, Inc. (22) · Drexel University (2) · Hospital Israelita Albert Einstein (2) · City of Hope Medical Center (1) · Weill Medical College of Cornell University (1)
United States (24) · Brazil (2) · Puerto Rico (1)
Jacob Lalezari, MD (8) · Stephen Morris, MD, PhD (2) · Angela Ritter, MD (1) · Edwin DeJesus, MD, FACP, (1) · Edwin DeJesus, MD, FIDSA (1) · Jeffrey Jacobson, MD (1) · Norman Gaylis, MD (1) · Pashtoon M Kasi (1) · Scott Kelly, MD (1) · Tracy A Butler, MD (1) · William Olson, PhD (1)
PMID 35358290, PMID 20377413, PMID 34868084, PMID 35452519, PMID 39353749, PMID 39972543
P30CA033572 (1), U01AI095085 (1), U19AI066329 (1)