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Clinical trials
catalyst calendar across sponsors →Studies where CYDY is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
20 interventional · 1 observational · 3 expanded access · 17 with posted results
Held by 1 tracked-famous manager (Ancora Advisors LLC) · FINRA short interest 9.9 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER)NCT06699836The efficacy of leronlimab in combination with trifluridine and tipiracil + bevacizumab in participants with relapsed, refractory, MSS, mCRC.Randomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: 350 mg leronlimab, 700 mg leronlimab | Metastatic Colorectal Cancer (mCRC) | 66 | Jan 2028 | ≤ 528 d | 2026-05-18 |
| Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal CancerNCT05730673Overall response rate (ORR, defined as Complete Response (CR) + Partial Response (PR)) in subjects with CCR5+ mCRC treated with Leronlimab (PRO 140) and Regorafenib.Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: No participants enrolled | Drug: 700mg leronlimab weekly dose, 80mg Regorafenib at week 1, 120mg Regorafenib at week2, 160 mg Regorafenib at week 3 | CCR5, Microsatellite Stable, Metastatic, Colorectal Cancer | 0 | 2023-05-27 | — | 2023-02-17 |
| Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBCNCT03838367results2025-09-09Phase I: Maximum Tolerated Dose (MTD) of Leronlimab (PRO 140) When Combined With Carboplatin AUC5Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Study terminated prematurely due to business reasons. Participants are no longer examined or receiving intervention. | Drug: 350 mg leronlimab, 525 mg leronlimab, 700 mg leronlimab, AUC 5 Carboplatin, Maximum Tolerated Dose (MTD) of leronlimab | Triple Negative Breast Neoplasms | 10 | 2022-07-15actual | — | 2025-09-09 |
| An Extension of Protocol PRO 140_CD01 StudyNCT02355184results2025-10-07Time to Virologic Failure After Initiating PRO 140 MonotherapyOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned. | Drug: PRO 140 350mg weekly subcutaneous (SC) injection. | HIV, Human Immunodeficiency Virus | 20 | Jun 2022actual | — | 2025-10-07 |
| An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label StudyNCT02990858results2025-11-12Mean Change in Viral Load (HIV-1 RNA Levels) at the Conclusion of Treatment PeriodOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Terminatedsponsor's stated reason: FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned. | Drug: PRO 140 | Human Immunodeficiency Virus (HIV) | 43 | Jun 2022actual | — | 2025-11-12 |
| An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 StudyNCT05271370results2025-10-30Long Term Clinical Safety of PRO 140 Monotherapy by Assessing the Number of Participants With Grade 2, 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale, and the Number of Participants With Treatment-emergent Serious Adverse Events.Non-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2/3 | Terminatedsponsor's stated reason: FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned. | Drug: PRO 140 350, PRO 140 525, PRO 140 700 | HIV-1-infection | 56 | 2022-06-20actual | — | 2025-10-30 |
| Leronlimab (PRO 140) in Patients With Nonalcoholic SteatohepatitisNCT04521114results2023-03-01MRI-PDFF Change From Baseline to Week 14Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ · Informed Consent Form ↗ | Phase 2 | Completed | Drug: Placebo, leronlimab 700 mg, leronlimab 350 mg | Nonalcoholic Steatohepatitis (NASH) | 87 | 2021-12-29actual | — | 2023-03-01 |
| Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid TumorsNCT04504942results2026-01-23Number of Participants With Adverse Events (AEs), and Serious Adverse Events (SAEs).Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Leronlimab | Solid Tumor, Adult | 16 | 2021-11-07actual | — | 2026-01-23 |
| Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19NCT04347239results2025-08-27All-cause Mortality at Day 28Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ · Informed Consent Form ↗ | Phase 2 | Completed | Drug: Placebo, Leronlimab (700mg) | Coronavirus Disease 2019 | 484 | 2021-10-24actual | — | 2025-10-15 |
| Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19NCT04678830results2024-04-11Changes From Baseline in Daily COVID-19-related Symptom Severity Score Through Day 56.Randomized · Quadruple-masked · TreatmentStudy Protocol, Statistical Analysis Plan, and Informed Consent Form ↗ | Phase 2 | Completed | Drug: Placebos, Leronlimab (700mg) | Coronavirus Disease 2019 | 56 | 2021-06-05actual | — | 2024-04-11 |
| A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell TransplantationNCT02737306results2024-03-12Incidence of Acute GVHD by Day 100Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Study terminated due to lack of enrolment.. | Drug: PRO 140, Placebo | Graft Vs Host Disease | 11 | 2021-04-14actual | — | 2024-03-12 |
| Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 InfectionNCT02859961results2026-03-04Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic FailureRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: PRO 140 (350 mg), PRO 140 (525 mg), PRO 140 (700 mg) | HIV | 562 | 2020-09-16actual | — | 2026-03-04 |
| Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19NCT04343651results2023-01-04Mean Change From Baseline in Total Symptom ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Placebo, Leronlimab (700mg) | Coronavirus Disease 2019 | 86 | 2020-07-21actual | — | 2023-01-04 |
| PRO 140 in Treatment-Experienced HIV-1 SubjectsNCT03902522results2025-09-16Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment PeriodOpen-label · TreatmentStudy Protocol ↗ | Phase 2/3 | Completed | Drug: PRO 140 | HIV-1-infection | 6 | 2020-05-18actual | — | 2025-09-16 |
| Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140NCT02483078results2022-11-03Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: PRO 140, Placebo, Optimized Background Regimen | HIV | 52 | Feb 2018actual | — | 2022-11-03 |
| 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 AdherenceNCT01272258Specific measure that will be used to determine the effect of the interventions: Percentage of subjects without virologic failure at week 24.Randomized · Quadruple-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Lack of enrollment | Drug: PRO 140, Placebo | HIV | 0 | Jan 2017 | — | 2017-02-02 |
| Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 InfectionNCT02175680results2023-04-14Time to Virologic Failure After Initiating PRO 140 Monotherapy.Open-label · Treatment | Phase 2 | Completed | Drug: PRO 140 · Other: Historical data | HIV, Human Immunodeficiency Virus | 43 | 2015-02-02actual | — | 2023-04-14 |
| Observational Study of Blood Treated With CytolinNCT01048372observationalT cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals. | — | Completed | — | HIV Infections | 20 | Jan 2011actual | — | 2013-05-21 |
| Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 InfectionNCT00642707results2013-05-31Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: PRO 140 (humanized monoclonal antibody to CCR5), Placebo Comparator | HIV -1 Infection, HIV Infections | 44 | Nov 2008actual | — | 2016-01-14 |
| PRO 140 by IV Administration in Adults With HIV-1 InfectionNCT00613379results2013-05-31Maximum Change in Viral Load Following Initiation of Treatment.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: PRO 140, PRO 140, Placebo | HIV Infections | 30 | Aug 2008actual | — | 2016-07-15 |
| Safety and Tolerability of PRO 140 in HIV Uninfected Male VolunteersNCT00110591results2023-03-14Safety and Tolerability of PRO 140Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: PRO 140 | HIV Infections | 20 | 2005-11-07actual | — | 2023-03-14 |
| An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 StudyNCT02759042expanded access | — | No longer available | Drug: PRO 140 | HIV | — | — | — | 2018-03-13 |
| A Compassionate Use Study of Leronlimab in Breast CancerNCT04313075expanded accessStudy Protocol ↗ · Statistical Analysis Plan ↗ | — | No longer available | Drug: Leronlimab | Metastatic Triple-Negative Breast Carcinoma | — | — | — | 2025-07-15 |
| 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)NCT07536815expanded access | — | Available | Drug: leronlimab (PRO 140) | TNBC, TNBC - Triple-Negative Breast Cancer, TNBC, Triple Negative Breast Cancer | — | — | — | 2026-04-27 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19