Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK … (NCT04605484) | Clinical Trial Compass
CompletedPhase 2
Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia
United States61 participantsStarted 2021-03-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)