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

BK Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605484
• Other study ID #: P-105-201
• Status: Completed
• Phase: Phase 2
• Start date: March 22, 2021
• Est. completion date: October 20, 2022

Study information

• Verified date: April 2024
• Source: AlloVir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• BK Virus Infection
• BK Virus Nephropathy
• Viremia

Intervention

Biological:
• Posoleucel (formerly known as ALVR105) cells
Infusion
• Placebo (visually identical to Posoleucel)
Infusion

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Piedmont Hospital	Atlanta	Georgia
United States	John Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Harvard Medical School - Brigham & Women's Hospital	Boston	Massachusetts
United States	Erie County Medical Center	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University Transplant Center	Chicago	Illinois
United States	University of Cincinnati Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Inova Fairfax Medical Center	Falls Church	Virginia
United States	UPMC Pinnacle-Harrisburg Hospital	Harrisburg	Pennsylvania
United States	Indiana University Hospital	Indianapolis	Indiana
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Keck Medical Center of USC	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Minnesota	Minneapolis	Minnesota
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	NYU Langone Medical Center	New York	New York
United States	Weil Medical College - NY Presbyterian Hospital	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Stanford University	Palo Alto	California
United States	UPMC Montefiore Hospital	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of California Davis Medical Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California, San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
AlloVir

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, Nair V, Chen LX, Alhamad T, Norman S, Cibrik D, Singh M, Alper A, Jain D, Zaky Z, Knechtle S, Sharfuddin A, Gupta G, Lonze BE, Young JH, Adey D, Faravardeh A, Dadhania DM, Rossi AP, Florescu D, Cardarelli F, Ma J, Gilmore S, Vasileiou S, Jindra PT, Wojciechowski D. Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. J Am Soc Nephrol. 2024 May 1;35(5):618-629. doi: 10.1681/ASN.0000000000000329. Epub 2024 Mar 12. No abstract available. — View Citation

Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs are defined as AEs with a start date and time on or after the first dose of study treatment through the end of study.; Clinically significant changes in vital signs, physical exams, laboratory assessments and electrocardiograms were also reported as TEAEs.	Day 1 to Week 24
Secondary	Change From Baseline in BK Viral Load	BK viral load was quantitated using polymerase chain reaction assays at the central laboratory. A negative change from baseline represents a reduction in BK viral load.	Baseline and Week 24