CYDY

CytoDyn, Inc.

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10Trials in this database

24Recorded changes · last 12 months

Partial coverageOnly the trials and history collected so far

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

Completion dates · Pro

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Included trials

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Trial	Sponsor	Phase	Status	Primary completion
An Extension of Protocol PRO 140_CD01 StudyNCT02355184	CytoDyn, Inc.	Phase 2	Terminated	2022-06Actual
A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell TransplantationNCT02737306	CytoDyn, Inc.	Phase 2	Terminated	2021-04-14Actual
Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 InfectionNCT02859961	CytoDyn, Inc.	Phase 2, Phase 3	Completed	2020-09-16Actual
An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label StudyNCT02990858	CytoDyn, Inc.	Phase 2, Phase 3	Terminated	2022-06Actual
PRO 140 in Treatment-Experienced HIV-1 SubjectsNCT03902522	CytoDyn, Inc.	Phase 2, Phase 3	Completed	2020-05-18Actual
Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19NCT04347239	CytoDyn, Inc.	Phase 2	Completed	2021-10-24Actual
Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid TumorsNCT04504942	CytoDyn, Inc.	Phase 2	Completed	2021-11-07Actual
Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19NCT04678830	CytoDyn, Inc.	Phase 2	Completed	2021-06-05Actual
An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 StudyNCT05271370	CytoDyn, Inc.	Phase 2, Phase 3	Terminated	2022-06-20Actual
CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched RegimenNCT06699836	CytoDyn, Inc.	Phase 2	Active not recruiting	2028-01Estimated

An Extension of Protocol PRO 140_CD01 Study

CytoDyn, Inc.TerminatedPrimary completion: 2022-06 · Actual

Trial details

Registry ID: NCT02355184
Phase: Phase 2

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

CytoDyn, Inc.TerminatedPrimary completion: 2021-04-14 · Actual

Trial details

Registry ID: NCT02737306
Phase: Phase 2

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

CytoDyn, Inc.CompletedPrimary completion: 2020-09-16 · Actual

Trial details

Registry ID: NCT02859961
Phase: Phase 2, Phase 3

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

CytoDyn, Inc.TerminatedPrimary completion: 2022-06 · Actual

Trial details

Registry ID: NCT02990858
Phase: Phase 2, Phase 3

PRO 140 in Treatment-Experienced HIV-1 Subjects

CytoDyn, Inc.CompletedPrimary completion: 2020-05-18 · Actual

Trial details

Registry ID: NCT03902522
Phase: Phase 2, Phase 3

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

CytoDyn, Inc.CompletedPrimary completion: 2021-10-24 · Actual

Trial details

Registry ID: NCT04347239
Phase: Phase 2

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

CytoDyn, Inc.CompletedPrimary completion: 2021-11-07 · Actual

Trial details

Registry ID: NCT04504942
Phase: Phase 2

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

CytoDyn, Inc.CompletedPrimary completion: 2021-06-05 · Actual

Trial details

Registry ID: NCT04678830
Phase: Phase 2

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

CytoDyn, Inc.TerminatedPrimary completion: 2022-06-20 · Actual

Trial details

Registry ID: NCT05271370
Phase: Phase 2, Phase 3

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

CytoDyn, Inc.Active not recruitingPrimary completion: 2028-01 · Estimated

Trial details

Registry ID: NCT06699836
Phase: Phase 2

Latest recorded trial changes

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

NCT06699836 · CytoDyn, Inc.

Posted 2026-05-18 · 3 fields changed

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

NCT06699836 · CytoDyn, Inc.

Posted 2026-04-03 · 1 field changed

Primary outcomes · main study measures

Text edit · unverified significance

− Previous value

measure: To evaluate the efficacy of leronlimab in combination with trifluridine and tipiracil + bevacizumab in participants with CCR5+, refractory, MSS, mCRC.

+ Updated value

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

The saved outcome text may be shortened. Check the source for full wording.

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

NCT02859961 · CytoDyn, Inc.

Posted 2026-03-04 · 2 fields changed

Primary outcomes · main study measures

Text edit · unverified significance

− Previous value

measure: Proportion of participants who remain on PRO 140 monotherapy regimen at the end of week 48 without experiencing virologic failure

+ Updated value

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

The saved outcome text may be shortened. Check the source for full wording.

Enrollment · participant count

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

NCT04504942 · CytoDyn, Inc.

Posted 2025-11-18 · 4 fields changed

Primary outcomes · main study measures

Text edit · unverified significance

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measure: Number, frequency, and severity of adverse events (AEs); measure: Incidence of abnormal laboratory tests results; measure: Changes in Eastern Cooperative Oncology Group (ECOG) performance status from baseline to subsequent scheduled visits

+ Updated value

measure: Number of Participants With Adverse Events (AEs), and Serious Adverse Events (SAEs).; measure: Changes in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Subsequent Scheduled Visits

The saved outcome text may be shortened. Check the source for full wording.

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Completed

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

NCT02990858 · CytoDyn, Inc.

Posted 2025-11-12 · 4 fields changed

Primary outcomes · main study measures

Text edit · unverified significance

− Previous value

measure: Mean change in viral load (HIV-1 RNA levels) at the conclusion of treatment period

+ Updated value

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

The saved outcome text may be shortened. Check the source for full wording.

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Terminated

Check registry source

An Extension of Protocol PRO 140_CD01 Study

NCT02355184 · CytoDyn, Inc.

Posted 2025-10-07 · 5 fields changed

Primary outcomes · main study measures

Text edit · unverified significance

− Previous value

measure: Time to virologic failure after initiating PRO 140 monotherapy.

+ Updated value

measure: Time to Virologic Failure After Initiating PRO 140 Monotherapy

The saved outcome text may be shortened. Check the source for full wording.

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Terminated

Check registry source

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

NCT05271370 · CytoDyn, Inc.

Posted 2025-10-02 · 5 fields changed

Primary outcomes · main study measures

Text edit · unverified significance

− Previous value

measure: Long term clinical safety of PRO 140 350mg, 525, or 700 mg monotherapy regimen will be measured based on participants With Treatment-Related Adverse Events; measure: Proportion of participants experiencing virologic failure, defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group will be measured

+ Updated value

measure: Long 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.; measure: Proportion of Participants Experiencing Virologic Failure for All Subjects Within Each Treatment Group.

The saved outcome text may be shortened. Check the source for full wording.

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2022-12-20

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2022-06-20

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Terminated

Check registry source