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

Study Overview
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Brief Summary
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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.

Official Title
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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
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BK Virus Nephropathy, BK Virus Infection

Intervention / Treatment
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* Biological: Posoleucel (formerly known as ALVR105) cells
* Biological: Placebo (visually identical to Posoleucel)


Participation Criteria
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Eligibility Criteria
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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. (If a matching Posoleucel line is not available, the following patient data will be collected: demographic data and human leukocyte antigen [HLA] type.) 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. A female patient is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: She is a woman of non-childbearing potential (WONCBP) as defined in the protocol She is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method as described in the protocol during the study treatment period and for at least 90 days after the last dose of study treatment. The Investigator should evaluate the potential for contraceptive method failure. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posoleucel<br>Arm 1: Regimen A | Biological: Posoleucel (formerly known as ALVR105) cells<br>* Infusion<br>|
| Experimental: Posoleucel and Placebo<br>Arm 2: Regimen B | Biological: Posoleucel (formerly known as ALVR105) cells<br>* Infusion<br>Biological: Placebo (visually identical to Posoleucel)<br>* Infusion<br>|
| Placebo Comparator: Placebo<br>Arm 3: Regimen A | Biological: Placebo (visually identical to Posoleucel)<br>* Infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Patients will be monitored for adverse events following each infusion and during the dosing period. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BK viremia, Posoleucel compared to placebo | Change in BK viral load in patients receiving Posoleucel compared to patients receiving placebo, based on mean +/- standard deviation of BK viral load as determined by the BK viral load assay performed at the central laboratory. | 24 weeks | 
| Change in BK viremia, different dose regimens of Posoleucel compared to placebo | Difference in mean BK viral load +/- standard deviation in Arm 1 versus placebo Arm 3, as compared to the difference in mean BK viral load in Arm 2 versus placebo Arm 3, -all as determined by the BK viral load assay performed at the central laboratory. | 24 weeks |