Source – 2seventy bio
On June 14, 2023, as a result of Seattle Children’s Therapeutics pausing a clinical study of their T cell treatment for acute myeloid leukemia (AML) following the death of a child, shares of 2seventy bio were down.
The Phase I PLAT-08 study, which began in 2021 with a target enrollment of 18 participants, is investigating SC-DARIC33, an autologous CAR-T treatment that targets CD33 on leukemia cells, in children and young adults with relapsed or refractory CD33-positive AML.
According to a recent update the therapy had been administered to three patients, according to a recent update. Initial data, which were presented at the American Society of Gene & Cell Therapy (ASGCT) last month, showed that one patient experienced the temporary elimination of leukemic cells as a result of treatment at the lowest planned dose.
According to a 2seventy bio statement, the fatality happened in the first patient in the Phase I study who received treatment at the second dosage level.
Like other CAR-Ts, SC-DARIC33 therapy needs patients to be comparatively strong due to the difficult nature of the procedure. In order to remove T cells from their blood and damage their bone marrow with lymphodepleting chemotherapy, they must be able to withstand the process of apheresis.
The company’s sole authorized CAR-T, Abecma (Idecabtagene Vicleucel), which is offered by Bristol-Myers Squibb, is not based on the platform, making this the first clinical test of the DARIC technology. An oncology branch of gene therapy expert bluebird bio is 2seventy bio.
“The safety of every patient who participates in our studies or is treated with our therapies is the utmost priority for us, and we are in communication with FDA while we assess the data surrounding this serious adverse event, and the potential next steps for the study.”
– Steve Bernstein, M.D., chief medical officer, 2seventy bio
