NCT01570283: ARMS

ARMS - Administration Of Rapidly Generated Multivirus-Specific Cytotoxic T-Lymphocytes For The Prophylaxis And Treatment Of EBV, CMV, Adenovirus, HHV6, And BK Virus Infections Post Allogeneic Stem Cell Transplant

Completed Phase 1/Phase 2 Results posted Last updated 9 May 2019

What this trial tests

Phase 1/Phase 2 trial testing Multivirus-specific T cells Dose Level 1 in Viral Infection in 21 participants. Completed in 1 September 2017.

Timeline

1 September 2012

Primary endpoint
1 August 2016

1 September 2017

Quick facts

Lead sponsor	AlloVir
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	1 September 2012
Primary completion	1 August 2016
Estimated completion	1 September 2017
Sites	2 locations across United States

Drugs / interventions tested

• Multivirus-specific T cells Dose Level 1 — full drug profile →
• Multivirus-specific T cells Dose Level 2 — full drug profile →
• Multivirus-specific T cells Dose Level 3 — full drug profile →

Conditions studied

• Viral Infection — all drugs for Viral Infection →

Sponsor

AlloVir — full company profile →

Who can join

Eligibility, any sex, with Viral Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With a DLT
  Time frame: 42 days
  DLT is defined as acute GvHD grades III-IV within 42 days of the last dose of CTLs, # of patients with Grade 3-5 infusion-related adverse events within 30 days of the last dose of CTLs, and # of patients with Grade 4-5 non-hematological adverse events within 30 days of the last dose of CTLs. GVHD grade III-IV scoring is based on the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) GVH

Sponsor's own description

The subjects eligible for this trial have a type of blood cell cancer, other blood disease or a genetic disease for which they will receive a stem cell transplant. The donor of the stem cells will be either the subject's brother or sister, or another relative, or a closely matched unrelated donor. The Investigators are asking subjects to participate in this study which tests if blood cells from the subject's donor that have been grown in a special way, can prevent or be a effective treatment for early infection by five viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV), adenovirus, BK virus (BKV) and human herpes virus 6 (HHV6).

The Investigators have grown T cells from the subject's stem cell donor in the laboratory in a way that will train them to recognize the viruses and control them when the T cells are given after a transplant. This treatment with specially trained T cells (also called cytotoxic T cells or "CTLs") has had activity against three of these viruses (CMV, EBV and Adenovirus) in previous studies. In this study the Investigators want to see if they increase the number of viruses that can be targeted to include BKV and HHV6 using a simple and fast approach to make the cells.

The Investigators want to see if they can use a kind of white blood cell called T lymphocytes (or T cells) to prevent and treat adenovirus, CMV, EBV, BKV and HHV6 in the early stages of reactivation or infection.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Activity of broad-spectrum T cells as treatment for AdV, EBV, CMV, BKV, and HHV6 infections after HSCT.
   Papadopoulou A, Gerdemann U, Katari UL, Tzannou I, et al · · 2014 · cited 305× · PMID 24964991 · DOI 10.1126/scitranslmed.3008825
2. Adoptive immunotherapy for primary immunodeficiency disorders with virus-specific T lymphocytes.
   Naik S, Nicholas SK, Martinez CA, Leen AM, et al · · 2016 · cited 93× · PMID 26920464 · DOI 10.1016/j.jaci.2015.12.1311
3. The time is now: moving toward virus-specific T cells after allogeneic hematopoietic stem cell transplantation as the standard of care.
   Saglio F, Hanley PJ, Bollard CM. · · 2014 · cited 60× · PMID 24438896 · DOI 10.1016/j.jcyt.2013.11.010
4. CAR-T cell therapy in T-cell malignancies: Is success a low-hanging fruit?
   Safarzadeh Kozani P, Safarzadeh Kozani P, Rahbarizadeh F. · · 2021 · cited 56× · PMID 34620233 · DOI 10.1186/s13287-021-02595-0
5. Respiratory Virus Infections in Hematopoietic Cell Transplant Recipients.
   Pochon C, Voigt S. · · 2018 · cited 45× · PMID 30687278 · DOI 10.3389/fmicb.2018.03294
6. Progress in Treatment of Viral Infections in Children with Acute Lymphoblastic Leukemia.
   Moschovi M, Adamaki M, Vlahopoulos SA. · · 2016 · cited 7× · PMID 27471584 · DOI 10.4081/oncol.2016.300
7. Long-term outcome of progressive multifocal leukoencephalopathy with recombinant interleukin-2 treatment and an associated increase in the number of HPyV-2-specific T-cells: a case report.
   Hoff FW, Rolwes J, Hardeman PA, Perkins M, et al · · 2023 · cited 4× · PMID 37822572 · DOI 10.1177/20406207231201721
8. Treating Adenovirus Infection in Transplant Populations: Therapeutic Options Beyond Cidofovir?
   Narsana N, Ha D, Ho DY. · · 2025 · cited 2× · PMID 40431613 · DOI 10.3390/v17050599