BK virus–specific T cells from healthy donors were an effective and safe off-the-shelf treatment for patients with leukemia or lymphoma who developed a painful and common complication after allogeneic hematopoietic stem cell transplantation.
BK virus (BKV)–associated hemorrhagic cystitis (BKV-HC) is a painful but common complication for patients with leukemia or lymphoma after allogeneic hematopoietic stem cell transplantation (AHSCT). However, BKV-specific T cells from healthy donors may safely and effectively treat BKV-HC.
The results of the phase 2 trial led by researchers at The University of Texas MD Anderson Cancer Center were published in Journal of Clinical Oncology.
The trial used BKV-specific cytotoxic T lymphocytes (BKV-CTLs) from 26 healthy donors that were banked for off-the-shelf use. Each donor’s blood sample could manufacture anywhere from 20 to 50 doses of antiviral T cells, which can be stored until they are needed. The cells were infused in 59 patients who developed BKV-HC after AHSCT.
The median age of the patients experiencing BKV-HC was 47 years and the most common hematological condition was acute myeloid leukemia. The majority of participants were men (59.3%) and White (55.9%). They received a single infusion and could receive additional infusions every 2 weeks if needed.
The researchers found that 67.7% had an overall response rate (ORR) at day 14. By day 45, the ORR increased to 81.6%. There were no cases of grade 3 or 4 graft-versus-host-disease or other infusion-related toxicities.
“We are extremely encouraged by the safety of this treatment and the rapid responses we’ve seen in the majority of patients,” corresponding author Katy Rezvani, MD, PhD, professor of Stem Cell Transplantation and Cellular Therapy, said in a statement. “Because this approach is so safe, we’ve been able to offer this treatment as an outpatient procedure as soon as patients begin developing symptoms. This has been life-changing for the patients we’ve been able to treat so far.”
The research was done with the support of the MDS and AML Moon Shot, part of the MD Anderson Moon Shots Program, a collaborative effort to rapidly develop scientific discoveries into meaningful clinical advances that save patients’ lives.
The researchers aim to validate the findings of this study in a multi-institutional study.
“Off-the-shelf BKV-CTLs are a safe and effective therapy for the management of patients with BKV-HC after AHSCT,” the authors concluded.
Olson A, Lin R, Marin D, et al. Third-party BK virus-specific cytotoxic T lymphocyte therapy for hemorrhagic cystitis following allotransplantation. J Clin Oncol. Published April 30, 2021. doi:10.1200/JCO.20.02608