Trial Outcomes & Findings for Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia (NCT NCT04605484)

Last Updated: 2024-05-16

Results Overview

An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs are defined as AEs with a start date and time on or after the first dose of study treatment through the end of study. Clinically significant changes in vital signs, physical exams, laboratory assessments and electrocardiograms were also reported as TEAEs.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

Day 1 to Week 24

Results posted on

2024-05-16

Participant Flow

Participants were enrolled at 26 sites in the United States between March 2021 and October 2022.

A total of 82 participants were screened during a 2-week screening period, of which 61 were randomized and received treatment.

Participant milestones

Participant milestones
Measure	Posoleucel (PSL) Group 1 Participants received PSL at a dose of 4 × 10\^7 cells as a slow push intravenous (IV) infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	PSL Group 2 Participants received PSL at a dose of 4 × 10\^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 28 days during the 12-week dosing period (5 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	Placebo Participants received placebo matching PSL as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of placebo). Participants continued to be observed for a 12-week follow-up.
Overall Study STARTED	20	22	19
Overall Study COMPLETED	20	20	18
Overall Study NOT COMPLETED	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Posoleucel (PSL) Group 1 Participants received PSL at a dose of 4 × 10\^7 cells as a slow push intravenous (IV) infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	PSL Group 2 Participants received PSL at a dose of 4 × 10\^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 28 days during the 12-week dosing period (5 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	Placebo Participants received placebo matching PSL as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of placebo). Participants continued to be observed for a 12-week follow-up.
Overall Study Lost to Follow-up	0	1	1
Overall Study Other	0	1	0

Baseline Characteristics

Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PSL Group 1 n=20 Participants Participants received PSL at a dose of 4 × 10\^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	PSL Group 2 n=22 Participants Participants received PSL at a dose of 4 × 10\^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 28 days during the 12-week dosing period (5 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	Placebo n=19 Participants Participants received placebo matching PSL as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of placebo). Participants continued to be observed for a 12-week follow-up.	Total n=61 Participants Total of all reporting groups
Age, Continuous	59.0 years n=5 Participants	54.0 years n=7 Participants	59.0 years n=5 Participants	58.0 years n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	49 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	52 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	22 participants n=7 Participants	19 participants n=5 Participants	61 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 to Week 24

Population: Safety Population: Included all participants who received any amount of PSL or placebo.

Outcome measures

Outcome measures
Measure	PSL Group 1 n=20 Participants Participants received PSL at a dose of 4 × 10\^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	PSL Group 2 n=22 Participants Participants received PSL at a dose of 4 × 10\^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 28 days during the 12-week dosing period (5 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	Placebo n=19 Participants Participants received placebo matching PSL as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of placebo). Participants continued to be observed for a 12-week follow-up.
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	17 Participants	17 Participants	16 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population: Included all randomized participant with Week 24 BK viral load data available.

BK viral load was quantitated using polymerase chain reaction assays at the central laboratory. A negative change from baseline represents a reduction in BK viral load.

Outcome measures

Outcome measures
Measure	PSL Group 1 n=19 Participants Participants received PSL at a dose of 4 × 10\^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	PSL Group 2 n=19 Participants Participants received PSL at a dose of 4 × 10\^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 28 days during the 12-week dosing period (5 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	Placebo n=17 Participants Participants received placebo matching PSL as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of placebo). Participants continued to be observed for a 12-week follow-up.
Change From Baseline in BK Viral Load	-0.830 log10 copies/mL Interval -2.08 to 0.11	-0.520 log10 copies/mL Interval -3.55 to 0.52	-0.330 log10 copies/mL Interval -2.08 to 0.27

Adverse Events

PSL Group 1

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

PSL Group 2

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PSL Group 1 n=20 participants at risk Participants received PSL at a dose of 4 × 10\^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	PSL Group 2 n=22 participants at risk Participants received PSL at a dose of 4 × 10\^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 28 days during the 12-week dosing period (5 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	Placebo n=19 participants at risk Participants received placebo matching PSL as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of placebo). Participants continued to be observed for a 12-week follow-up.
Immune system disorders Transplant rejection	0.00% 0/20 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	4.5% 1/22 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/19 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.
Infections and infestations Enterococcal bacteraemia	0.00% 0/20 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	4.5% 1/22 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/19 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.
Infections and infestations Pyelonephritis	5.0% 1/20 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/22 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/19 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.
Infections and infestations Renal tuberculosis	5.0% 1/20 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/22 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/19 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.
Infections and infestations Urosepsis	5.0% 1/20 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/22 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/19 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.
Renal and urinary disorders Proteinuria	0.00% 0/20 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	4.5% 1/22 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/19 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	5.0% 1/20 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/22 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.	0.00% 0/19 • Day 1 to Week 24 Safety Population: Included all participants who received any amount of PSL or placebo.

Other adverse events

Additional Information

Richard Riese

AlloVir, Inc.

Phone: 617-433-2605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place