NCT04605484

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

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT04605484

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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

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

Disease(s) and\or Condition(s)

BK Virus Nephropathy

BK Virus Infection

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: Posoleucel (formerly known as ALVR105) cells
- Description: Infusion
- Arm Group Labels: Posoleucel, Posoleucel and Placebo
- Type: BIOLOGICAL
- Name: Placebo (visually identical to Posoleucel)
- Description: Infusion
- Arm Group Labels: Placebo, Posoleucel and Placebo

Sponsor

AlloVir