Study of Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

Sponsor

AlloVir (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05305040

Collaborator

(none)

302

Enrollment

Locations

Arms

31.3

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 3 study to evaluate posoleucel (ALVR105, formerly Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

Condition or Disease	Intervention/Treatment	Phase
Adenovirus Infection BK Virus Infection Cytomegalovirus Infections Epstein-Barr Virus Infections Human Herpes Virus-6 Infection JC Virus Infection	Biological: Posoleucel (ALVR105) Biological: Placebo	Phase 2/Phase 3

Detailed Description

This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT.

There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

302 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant

Actual Study Start Date :

Mar 21, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Oct 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Posoleucel (ALVR105) Administered as 2-4 milliliter infusion, visually identical to placebo	Biological: Posoleucel (ALVR105) Administered as 2-4 milliliter infusion, visually identical to placebo Other Names: Viralym-M
Placebo Comparator: Placebo Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)	Biological: Placebo Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Arm

Intervention/Treatment

Active Comparator: Posoleucel (ALVR105)

Administered as 2-4 milliliter infusion, visually identical to placebo

Biological: Posoleucel (ALVR105)

Administered as 2-4 milliliter infusion, visually identical to placebo

Other Names:

Viralym-M

Placebo Comparator: Placebo

Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Biological: Placebo

Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Outcome Measures

Primary Outcome Measures

Number of clinically significant infections or episodes of end-organ disease [Through Week 14]

Secondary Outcome Measures

Number of clinically significant infections or episodes of end-organ disease [Through Week 26]
Number of clinically significant infections or episodes of end-organ disease due to each virus [Through Week 14 and 26]
Mean area under the curve (AUC) viral load [Through Week 14 and 26]
Incidence of Adverse Events [Through Week 26]
Overall and Non-Relapse Mortality [Through Week 26]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

≥1 year of age at the day of screening visit.
No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment
Meet one or more of the following criteria at the time of randomization:
Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
Haploidentical donor
Matched or Mismatched unrelated donor
Use of umbilical cord blood as stem cell source
Ex vivo graft manipulation resulting in T cell depletion
Received anti-thymocyte globulin or alemtuzumab (Campath-1H)

Key Exclusion Criteria:

History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
Evidence of active Grade >2 acute GVHD
Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day) within 24 hours prior to dosing
Relapse of primary malignancy other than minimal residual disease

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	City of Hope	Duarte	California	United States	91010
3	Stanford University	Palo Alto	California	United States	94306
4	University of California, San Francisco Medical Center	San Francisco	California	United States	94143
5	University of Colorado Hospital	Aurora	Colorado	United States	80045
6	Yale University School of Medicine	New Haven	Connecticut	United States	06510
7	Children's National Medical Center	Washington	District of Columbia	United States	20010
8	University of Florida - Division of Hematology & Oncology	Gainesville	Florida	United States	32610
9	Moffitt	Tampa	Florida	United States	33612
10	Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30322
11	Northside Hospital	Atlanta	Georgia	United States	30342
12	Indiana University Hospital	Indianapolis	Indiana	United States	46202
13	University of Kansas Cancer Center	Kansas City	Kansas	United States	64116.
14	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
15	Johns Hopkins Medicine	Baltimore	Maryland	United States	21287
16	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
17	University of Minnesota	Minneapolis	Minnesota	United States	55455
18	Children's Mercy Hospital - Kansas City	Kansas City	Missouri	United States	64108
19	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
20	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
21	Roswell Park Comprehensive Cancer Center	Buffalo	New York	United States	14203
22	Weil Medical College - NY Presbyterian Hospital	New York	New York	United States	10021
23	Columbia University	New York	New York	United States	10032
24	Mayo Clinic	Rochester	New York	United States	55905
25	Stony Brook University Hospital Cancer Center	Stony Brook	New York	United States	11794
26	Levine Cancer Center	Charlotte	North Carolina	United States	28203
27	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
28	Oregon Health & Science University	Portland	Oregon	United States	97239
29	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
30	Medical University of South Carolina	Charleston	South Carolina	United States	29425
31	Baylor University Medical Center	Dallas	Texas	United States	75204
32	Children's Medical Center Dallas	Dallas	Texas	United States	75235
33	University of Virginia	Charlottesville	Virginia	United States	22908
34	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
35	Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
36	Centre Hospitalier Regional Universitaire de Lille	Lille		France
37	CHU de Nantes	Nantes		France
38	Hopital Saint Antoine	Paris		France
39	Hopital Universitaire Robert Debre	Paris		France
40	Hospital Saint-Louis	Paris		France
41	Centre Hospitalier Lyon Sud	Pierre-Bénite		France
42	Institut Claudius Regaud Cancer Comprehensive Center - IUCT Oncopole	Toulouse		France
43	Azienda Ospedaliero-Universitaria Careggi	Firenze		Italy
44	IRCCS Ospedale San Raffaele	Milano		Italy
45	Fondazione I.R.C.C.S. Policlinico San Matteo	Pavia		Italy	27100
46	Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore	Rome		Italy
47	Istituto Clinico Humanitas	Rozzano		Italy
48	Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento	Verona		Italy
49	Chonnam National University Hwasun Hospital	Hwasun		Korea, Republic of
50	Pusan National University Hospital	Seoul		Korea, Republic of
51	Samsung Medical Center	Seoul		Korea, Republic of
52	Seoul National University Hospital	Seoul		Korea, Republic of
53	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul		Korea, Republic of
54	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of
55	Institut Catala d'Oncologia	Barcelona		Spain
56	Hospital General Universitario Gregorio Maranon	Madrid		Spain
57	Unidad De Hemofilia, Hospital Regional Universitario De Malaga	Málaga		Spain
58	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain
59	Bristol Haematology and Oncology Centre	Bristol		United Kingdom
60	Queen Elizabeth University Hospital	Glasgow		United Kingdom
61	King's College Hospital	London		United Kingdom