Phase 2
N=61
Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia
BK Virus Nephropathy · BK Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04605484 ↗Enrolled (actual)
61
Serious AEs
6.6%
Results posted
May 2024
Primary outcome: Primary: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) — 17; 17; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Posoleucel (formerly known as ALVR105) cells (Biological); Placebo (visually identical to Posoleucel) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AlloVir
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) |
17; 17; 16 | — |
| SECONDARY Change From Baseline in BK Viral Load |
-0.830; -0.520; -0.330 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04605484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.