| Vyrologix (leronlimab) / CytoDyn, Vyera Pharma, amfAR |
2020-001996-33: A Phase 2b/3 Study to Evaluate the Efficacy and Safety of Leronlimab for Patients with Severe or Critical Coronavirus Disease 2019 (COVID-19) |
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| Not yet recruiting | 3 | 290 | Europe | Leronlimab(PRO 140), Injection, Leronlimab Injection 175mg/ml (PRO-140) | CytoDyn, Inc., CytoDyn, Inc. | Coronavirus Disease 2019 (COVID-19), Coronavirus Disease, Diseases [C] - Virus Diseases [C02] | | | | |
NCT02990858: An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study |
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| Active, not recruiting | 2/3 | 44 | NA | PRO 140 SC injections | CytoDyn, Inc. | Hiv, Human Immunodeficiency Virus | 06/22 | 08/22 | | |
NCT03902522: PRO 140 in Treatment-Experienced HIV-1 Subjects |
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| Active, not recruiting | 2/3 | 25 | US | PRO 140, Leronlimab | CytoDyn, Inc. | HIV-1-infection | 07/22 | 08/22 | | |
| Active, not recruiting | 2/3 | 56 | US | PRO 140 350, PRO 140 525, PRO 140 700 | CytoDyn, Inc. | HIV-1-infection | 12/22 | 04/23 | | |
NCT02859961: Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection |
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| Active, not recruiting | 2b | 556 | US | PRO 140 (350 mg), Leronlimab, PRO 140 (525 mg), PRO 140 (700 mg) | CytoDyn, Inc. | HIV | 09/20 | 06/22 | | |
NCT04347239 / 2020-001996-33: Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19) |
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| Active, not recruiting | 2b | 394 | US | Placebos, Leronlimab (700mg) | CytoDyn, Inc., CytoDyn, Inc. | Coronavirus Disease 2019 | 10/21 | 06/22 | | |
NCT04504942: Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors |
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| Active, not recruiting | 2 | 30 | US | Leronlimab | CytoDyn, Inc., Amarex Clinical Research | Solid Tumor, Adult | 11/21 | 07/22 | | |
NCT04521114: Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis |
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| Completed | 2 | 87 | US | Placebo, leronlimab 700 mg, PRO 140, leronlimab 350 mg | CytoDyn, Inc., Amarex Clinical Research | Nonalcoholic Steatohepatitis (NASH) | 12/21 | 12/21 | | |
| Active, not recruiting | 2 | 28 | US | PRO 140 350mg weekly SQ injection., PRO 140 | CytoDyn, Inc. | HIV, Human Immunodeficiency Virus | 06/22 | 08/22 | | |
NCT05730673: Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer |
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| Withdrawn | 2 | | NA | 700mg leronlimab weekly dose, 80mg Regorafenib at week 1, 120mg Regorafenib at week2, 160 mg Regorafenib at week 3 | CytoDyn, Inc., Amarex Clinical Research | CCR5, Microsatellite Stable, Metastatic, Colorectal Cancer | 05/23 | 08/23 | | |
NCT06699836: A Phase 2 Study of Leronlimab in Combination with TAS-102 + Bevacizumab in Previously Treated Participants with MCRC |
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| Not yet recruiting | 2 | 60 | NA | 350 mg leronlimab, PRO 140, 700 mg leronlimab | CytoDyn, Inc., Syneos Health | Metastatic Colorectal Cancer (mCRC) | 06/28 | 08/28 | | |
NCT03838367: Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC |
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| Active, not recruiting | 1/2 | 48 | US | 350 mg leronlimab, PRO 140, 525 mg leronlimab, 700 mg leronlimab, AUC 5 Carboplatin, Maximum Tolerated Dose (MTD) of leronlimab | CytoDyn, Inc., Amarex Clinical Research | Triple Negative Breast Neoplasms | 07/22 | 09/22 | | |
CD02_EA, NCT02759042: An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study |
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| No Longer Available | N/A | | US | PRO 140, PRO140, CCR5 antagonist, Humanized monoclonal antibody to CCR5 | CytoDyn, Inc., Amarex Clinical Research | HIV | | | | |
NCT04313075: A Compassionate Use Study of Leronlimab in Breast Cancer |
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| No Longer Available | N/A | | NA | Leronlimab, (PRO 140) | CytoDyn, Inc. | Metastatic Triple-Negative Breast Carcinoma | | | | |
