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

AlloVir

Status and phase: Completed; Phase 2

Conditions: BK Virus Nephropathy; BK Virus Infection

Treatments: Biological: Placebo (visually identical to Posoleucel); Biological: Posoleucel (formerly known as ALVR105) cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT04605484

P-105-201

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 3 patient groups, including a placebo group

Posoleucel

Experimental group

Description:

Arm 1: Regimen A

Treatment:

Biological: Posoleucel (formerly known as ALVR105) cells

Posoleucel and Placebo

Experimental group

Description:

Arm 2: Regimen B

Treatment:

Biological: Posoleucel (formerly known as ALVR105) cells

Biological: Placebo (visually identical to Posoleucel)

Placebo

Placebo Comparator group

Description:

Arm 3: Regimen A

Treatment:

Biological: Placebo (visually identical to Posoleucel)