Trial Outcomes & Findings for Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors (NCT NCT04504942)

Last Updated: 2026-01-23

Results Overview

Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months)

Results posted on

2026-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Leronlimab 525mg Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Overall Study STARTED	16
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Leronlimab 525mg Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Overall Study Withdrawal by Subject	2
Overall Study 7 patients were on-going at the time when study was closed by sponsor.	7
Overall Study Disease Progression	1

Baseline Characteristics

No birthday information was included for 1 patient.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leronlimab 525mg n=16 Participants Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Age, Categorical <=18 years	0 Participants n=15 Participants • No birthday information was included for 1 patient.
Age, Categorical Between 18 and 65 years	12 Participants n=15 Participants • No birthday information was included for 1 patient.
Age, Categorical >=65 years	3 Participants n=15 Participants • No birthday information was included for 1 patient.
Age, Continuous	54.87 years STANDARD_DEVIATION 15.36 • n=15 Participants • No birthday information was included for 1 patient.
Sex: Female, Male Female	8 Participants n=16 Participants
Sex: Female, Male Male	8 Participants n=16 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=16 Participants
Race (NIH/OMB) Asian	2 Participants n=16 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants
Race (NIH/OMB) Black or African American	0 Participants n=16 Participants
Race (NIH/OMB) White	14 Participants n=16 Participants
Race (NIH/OMB) More than one race	0 Participants n=16 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants
Region of Enrollment United States	16 participants n=16 Participants

PRIMARY outcome

Timeframe: From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months)

Population: The population (N=16) consists of all subjects who received at least one dose of leronlimab (PRO 140).

Outcome measures

Outcome measures
Measure	Leronlimab 525mg n=16 Participants Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Number of Participants With Adverse Events (AEs), and Serious Adverse Events (SAEs). Adverse Events	11 Participants
Number of Participants With Adverse Events (AEs), and Serious Adverse Events (SAEs). Serious Adverse Events	3 Participants

PRIMARY outcome

Timeframe: From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months)

Population: The population (N=16) consists of all subjects who received at least one dose of leronlimab (PRO 140). Subjects who had undefined change from baseline due to missing data were excluded from the analysis population.

The ECOG was utilized to assess the ability of patients to tolerate treatment. The ECOG is a 5-point scale, where a higher score indicates a greater lack of tolerance of the treatment. Response choices included: 0 = Asymptomatic; Fully active, able to carry on all pre-disease performance without restriction, 1 = Symptomatic but completely ambulatory; Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2 = Symptomatic, \<50% in bed during the day; Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours, 3 = Symptomatic, \>50% in bed during the day; Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours, 4 = Bedbound; Completely disabled; cannot carry on any selfcare; totally confined to bed or chair, 5 = Dead.

Outcome measures

Outcome measures
Measure	Leronlimab 525mg n=16 Participants Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Changes in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Subsequent Scheduled Visits Participants with improved ECOG score	2 Participants
Changes in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Subsequent Scheduled Visits Participants with stable ECOG score	2 Participants
Changes in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Subsequent Scheduled Visits Participants with worsened ECOG score	2 Participants
Changes in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Subsequent Scheduled Visits Missing data	10 Participants

SECONDARY outcome

Timeframe: The time in months from start of treatment to progression or death will be measured for all patients who receive at least one dose of study drug. Participants were followed on study until last study visit completion up to approximately 16 months.

Population: The population (N=16) consists of all subjects who received at least one dose of leronlimab (PRO 140). Censor subjects are all subjects who did not have a disease progression or death.

The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria was used for objective tumor response assessment (when disease is measurable and non- measurable); PFS is calculated from the date of first dose of leronlimab until date of clinical progressions.

Outcome measures

Outcome measures
Measure	Leronlimab 525mg n=16 Participants Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Progression Free Survival (PFS) Defined as Time in Months From the Date of First Study Treatment to the Date of Disease Progression or Death From Any Cause, Whichever Comes First.	4.05 months Standard Deviation 2.758

SECONDARY outcome

Population: The population consists of all subjects who received at least one dose of leronlimab (PRO 140). Subjects who had undefined change from baseline due to missing data were excluded from the analysis population.

Overall response rate is defined as the percentage of patients who achieve an overall response of complete response or partial response in the total number of evaluable patients, assessed by RECIST v1.1.

Outcome measures

Outcome measures
Measure	Leronlimab 525mg n=11 Participants Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Overall Response Rate (ORR, Defined as CR (Complete Response) + PR (Partial Response)) in Subjects With CCR5+ Locally Advanced or Metastatic Solid Tumors Treated With Leronlimab.	18.2 percentage of participants

SECONDARY outcome

Timeframe: From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months).

Population: The population consists of all subjects who received at least one dose of leronlimab (PRO 140). Subjects who had undefined or missing data from baseline were excluded from the analysis population.

Recorded time from baseline metastatic disease (at time of enrollment) to the time of development of new metastasis in different site. New metastases in same site will be also recorded. TTNM will be calculated according to the formula: TTNM=(Date of new metastases - Date of first treatment) + 1.

Outcome measures

Outcome measures
Measure	Leronlimab 525mg n=16 Participants Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Mean Time to New Metastases (TTNM)	286 days Standard Deviation 0

SECONDARY outcome

Timeframe: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first. From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months).

Reported unit of measure will be the number of CTCs/milliliters. CTCs enumeration will be performed at baseline and at the time of response assessment. Fraction of baseline positive and change from ≥5 CTCs will be recorded and reported.

Outcome measures

Outcome measures
Measure	Leronlimab 525mg n=1 Participants Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
The Change From Baseline in Circulating Tumor Cells (CTC) Level in the Peripheral Blood.	22 CTCs/milliliters

SECONDARY outcome

Timeframe: Overall survival is calculated by long-term follow-up date - PRO 140 (leronlimab) start date, up to approximately 57 months.

Population: The population consists of all subjects who received at least one dose of leronlimab (PRO 140). Censor subjects are all subjects who had a long-term follow up date.

Overall survival defined as time in months from the date of first study treatment to the date of death. Patients will be followed from the start of treatment (first dose) until long-term follow up date (up to 2 years post-treatment or death), whichever occurs first, and average survival time will be measured.

Outcome measures

Outcome measures
Measure	Leronlimab 525mg n=16 Participants Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Overall Survival Defined as Time in Months From the Date of First Study Treatment to the Date of Death	53.60 months Standard Deviation 3.956

Adverse Events

Leronlimab 525mg

Serious events: 3 serious events

Other events: 11 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Leronlimab 525mg n=16 participants at risk Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Infections and infestations Sepsis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Renal and urinary disorders Urinary retention	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.

Other adverse events

Other adverse events
Measure	Leronlimab 525mg n=16 participants at risk Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Leronlimab: Drug: Leronlimab 525mg
Skin and subcutaneous tissue disorders Alopecia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Psychiatric disorders Anxiety	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Musculoskeletal and connective tissue disorders Arthritis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
General disorders Chills	12.5% 2/16 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Gastrointestinal disorders Constipation	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Infections and infestations COVID-19	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Musculoskeletal and connective tissue disorders Exostosis	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
General disorders Fatigue	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Nervous system disorders Headache	12.5% 2/16 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Metabolism and nutrition disorders Hypokalaemia	12.5% 2/16 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Endocrine disorders Hypothyroidism	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
General disorders Injection site rash	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
General disorders Injection site reaction	12.5% 2/16 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Psychiatric disorders Insomnia	12.5% 2/16 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Musculoskeletal and connective tissue disorders Joint swelling	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Infections and infestations Localized infection	6.2% 1/16 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Vascular disorders Lymphoedema	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Gastrointestinal disorders Nausea	12.5% 2/16 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Skin and subcutaneous tissue disorders Night sweats	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
General disorders Oedema peripheral	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Musculoskeletal and connective tissue disorders Pain in jaw	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
General disorders Pyrexia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Cardiac disorders Tachycardia	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
General disorders Vaccination site reaction	6.2% 1/16 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were reported from the time of the first treatment and continued up until the final study visit (EOT visit) to evaluate safety of leronlimab (PRO 140) (up to approximately 16 months). All-cause mortality was assessed from first dose through the long-term follow-up period (up to approximately 57 months). Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.

Additional Information

Vice President, Clinical Operations

CytoDyn

Phone: 3609808524

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place