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leronlimab

Generic: Leronlimab

leronlimab: developed by 1 company · 10 clinical trials tracked.

leronlimab evidence translation

What we can confirm

10 tracked trials

What it means

Source-backed records connect leronlimab to CYDY; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could leronlimab → CYDY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Solid Tumor, Adult; Metastatic Triple-Negative Breast Carcinoma; TNBC

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
CytoDyn Inc. (CYDY)
Solid Tumor, Adult; Metastatic Triple-Negative Breast Carcin…
Phase 2
Clinical Trials (10)

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)

Available
Expanded Access1 site · United StatesCytoDyn, Inc.

A Compassionate Use Study of Leronlimab (PRO 140) Plus Treatment of Physician's Choice in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)

No longer available
Expanded AccessCytoDyn, Inc.

Safety Assessment of Leronlimab and Its Effect on Neuroinflammation Targets in Alzheimer's Disease

NCT07553338·Phase 2
Recruiting

Primary endpoint: Mean change from baseline in whole-brain inflammation using 11C-DPA-713 Positron Emission Tomography (PET)

Interventionalopen20 targetStarted 2026-04Completion 2027-111 site · United StatesWeill Medical College of Cornell University

A Phase Two Study Evaluating Two Doses of Leronlimab (PRO 140) In Combination With Trifluridine + Tipiracil (TAS-102) + Bevacizumab in Participants With Microsatellite Stable (MSS), Relapsed Refractory Metastatic Colorectal Cancer (mCRC)

NCT06699836·Phase 2·CYDY
Active, not recruiting

Primary endpoint: The efficacy of leronlimab in combination with trifluridine and tipiracil + bevacizumab in participants with relapsed, refractory, MSS, mCRC.

InterventionalRandomizedopen66 targetStarted 2025-06Completion 2028-037 sites · United StatesCytoDyn, Inc.

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

NCT04504942·Phase 2·CYDY
Completed

Primary endpoint: Number of Participants With Adverse Events (AEs), and Serious Adverse Events (SAEs).

Interventionalopen16 enrolledStarted 2020-05Completion 2025-011 site · United StatesCytoDyn, Inc.

A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)

NCT04347239·Phase 2·CYDY
Completed

Primary endpoint: All-cause Mortality at Day 28

InterventionalRandomizedquadruple484 enrolledStarted 2020-04Completion 2022-0618 sites · United StatesCytoDyn, Inc.

A Phase Ib/II Study of Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)

NCT03838367·Phase 2·CYDY
Terminated

Primary endpoint: Phase I: Maximum Tolerated Dose (MTD) of Leronlimab (PRO 140) When Combined With Carboplatin AUC5

Interventionalopen10 targetStarted 2019-04Completion 2022-092 sites · United StatesCytoDyn, Inc.

A Multi-center, Two-Part, Single-Arm, Open Label, 25-Week Trial With PRO 140 in Treatment-Experienced HIV-1 Subjects

NCT03902522·Phase 3·CYDY
Completed

Primary endpoint: Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment Period

Interventionalopen6 enrolledStarted 2018-06Completion 2020-0517 sites · United StatesCytoDyn, Inc.

A Phase 2b/3, Multicenter Study to Assess the Treatment Strategy of Using PRO 140 SC as Long-Acting Single-Agent Maintenance Therapy for 48 Weeks in Virologically Suppressed Subjects With CCR5-tropic HIV-1 Infection

NCT02859961·Phase 2/Phase 3·CYDY
Completed

Primary endpoint: Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic Failure

InterventionalRandomizedopen562 enrolledStarted 2016-12Completion 2020-1212 sites · United StatesCytoDyn, Inc.

An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study

NCT02990858·Phase 3·CYDY
Terminated

Primary endpoint: Mean Change in Viral Load (HIV-1 RNA Levels) at the Conclusion of Treatment Period

Interventionalopen43 targetStarted 2016-11Completion 2022-07CytoDyn, Inc.

Frequently asked questions

Who is developing leronlimab?

leronlimab is being developed by CytoDyn Inc..

How many clinical trials involve leronlimab?

BioSniper tracks 10 clinical trials involving leronlimab.