Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Dosing Interval, 3-period Study of the Safety, Tolerability and Effectiveness of Adoptively Transferred ALVR105 (Viralym-M) Multivirus-specific T Cells in Kidney Transplant Recipients With Either High or Low Levels of BK Viremia

Keywords

BK Virus Nephropathy BK Virus Infection Viremia Posoleucel (formerly known as ALVR105; Viralym-M) cells Posoleucel

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients who had a kidney transplant performed greater than or equal to 28 days prior to enrollment
  • At least 1 identified, suitably matched Posoleucel (Viralym-M) cell line for infusion is available. (If a matching Posoleucel (Viralym-M) 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.

You CAN'T join if...

  • 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, belatacept, sirolimus or everolimus within 3 months of screening

Locations

  • University of California, San Francisco Medical Center not yet accepting patients
    San Francisco California 94143 United States
  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AlloVir
ID
NCT04605484
Phase
Phase 2
Study Type
Interventional
Last Updated