T cell therapy effective against painful complication of stem cell transplants

Image credit MD Anderson

CANCER DIGEST – May 3, 2021 – An infusion of specific T cells from healthy donors were safe and effective as an off-the-shelf therapy for a common painful complication of allogeneic (donor) stem cell patients, a new clinical trial shows. The study appears in the April 30, 2021 Journal of Clinical Oncology.
BKV-associated hemorrhagic cystitis (BKV-HC), is a painful complication common after stem cell transplants for patients with leukemia or lymphoma. The cause is a re-emergence of the BK virus, which can cause painful inflammation and bleeding of the lining of the urinary bladder, urinary obstruction, and abnormal kidney function.

“BKV-associated hemorrhagic cystitis is an incredibly painful condition that causes significant morbidity in patients and can lead to worse cancer outcomes in the long term. Unfortunately, there are no effective treatments available,” said corresponding author Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy. “We were driven to develop this therapy to provide a better option for these patients, and this has emerged as a safe and effective therapy for patients at MD Anderson based on these results.”

In the small Phase 2 study led by researchers at M.D. Anderson Cancer Center involved 59 patients experiencing BKV-HC following allogeneic stem cell transplant. Patients received a single infusion of patient-matched T cells that target the BK virus. Patients had the option of additional infusions if needed.

The 14 day overall response rate was 67.7% with 40 of 49 who were evaluated had reduced symptoms. The response rate increased to 81.6 percent after 45 days. When compared to similar patients treated with standard therapy, the T cell therapy had better response rates at all timepoints following stem cell transplant.

“We are extremely encouraged by the safety of this treatment and the rapid responses we’ve seen in the majority of patients,” Rezvani said. “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 researchers plan to validate these findings in a multi-institutional study and bring this treatment option to many more patients in need.

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Sources: MD Anderson press release and Journal of Clinical Oncology