Phase 2 Completed N=61 Randomized Quadruple-blind Treatment

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

BK Virus Nephropathy · BK Virus Infection

Source: ClinicalTrials.gov NCT04605484 ↗

Enrolled (actual)

Serious AEs

6.6%

Results posted

May 2024

Primary outcomePrimary: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) — 17; 17; 16 Participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.