The assistant professor at Mayo Clinic School of Medicine discussed the design of the phase 1 trial.
“Currently, we've added a few arms where we are trying to prime the immune system for the patients to have a better immune response post VSV therapy. So, we are giving a one-time infusion of checkpoint blockers, pre VSV therapy, and that arm just recently opened, and it is currently enrolling. So very exciting things for our patients. And we are hoping, if we confirm whatever responses we are seeing, to potentially get to submit our data to the FDA.”
A phase 1 clinical trial (NCT03017820) being conducted at Mayo Clinic is evaluating VSV-IFNβ-NIS, an engineered Vesicular Stomatitis Virus therapy, in patients with relapsed/refractory multiple myeloma and T-cell lymphoma (TCL). VSV-IFNβ-NIS is a bullet-shaped rhabdovirus which encodes both interferon beta (IFNβ) and sodium iodine symporter (NIS) with particular tumor cell tropism. Study investigator N Nora Bennani, MD, assistant professor, Mayo Clinic College of Medicine, presented the trial design at the 2023 American Society of Hematology (ASH) Annual Meeting & Exposition, held December 9-12, in San Diego, California.
Patients receive 5 × 109, 1.7 × 1010, 5 × 1010, or 1.7 × 1011 TCID50 VSV-IFNβ-NIS as well as acetaminophen and diphenhydramine hydrochloride. Two expansion cohorts at DL4 have been added with 20 additional patients with peripheral TCL, and 10 with B-cell lymphoma and histiocytic neoplasms. CGTLive® spoke with Bennani to learn more about the trial and the potential advantages of VSV-IFNβ-NIS in these indications. She also shared the background of the trial, expanded on the mechanism of the therapy, and shared responses that have been seen with it historically.
Bendamustine Is an Effective Alternative to Fludarabine-Based Lymphodepletion in LBCL
December 7th 2024In the wake of fludarabine shortages, lemphodepletion with bendamustine was found to be an effective alternative compared for patients with large B-cell lymphoma being treated with a CD19-directed CAR T-cell therapy.