NCT04605484CompletedPhase 2
Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Dosing Interval, 2-period Study of the Safety, Tolerability and Effectiveness of Adoptively Transferred Posoleuccel (ALVR105) Multivirus-specific T Cells in Kidney Transplant Recipients With Either High or Low Levels of BK Viremia
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AlloVir
- Enrollment
- 61
- Locations
- 66
- Primary Endpoint
- Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Study Overview
Brief Summary
The purpose of this study is to compare Posoleucel (formerly known as ALVR105; Viralym-M) to placebo in kidney transplant recipients who have high or low levels of BK virus in their blood.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who had a kidney transplant performed greater than or equal to 28 days prior to enrollment
- •At least 1 identified, suitably matched Posoleucel (ALVR105) cell line for infusion is available.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
- •Undergone allogeneic hematopoietic cell transplantation
- •Evidence or history of graft versus host disease (GVHD) or cytokine release syndrome (CRS).
- •Uncontrolled or progressive bacterial or fungal infections
- •Known or presumed pneumonia
- •Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
- •Pregnant or lactating or planning to become pregnant.
- •Weight <40 kg.
- •Patients who received, or planned to receive abatacept or belatacept, within 3 months of screening
Outcomes
Primary Outcomes
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time Frame: Day 1 to Week 24
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.
Secondary Outcomes
- Change From Baseline in BK Viral Load(Baseline and Week 24)
Investigators
Study Sites (66)
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