On September 14, 2026 Vyriad, Inc., a clinical-stage biotechnology company developing targeted genetic therapies for cancer and other serious diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a clinical trial of VV169, an off-the-shelf, in vivo CAR T cell therapy targeting BCMA in patients with relapsed/refractory multiple myeloma. The Phase 1 trial is now open for enrollment at Mayo Clinic.

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"VV169 is designed to create CAR-T cells directly inside the body, offering a new way of delivering this powerful therapeutic approach to patients with multiple myeloma. The Phase 1 clinical trial for VV169 being open for enrollment is a significant milestone for Vyriad and we are proud to reach it alongside Dr. Yi Lin and her team at Mayo Clinic," said Luke Russell, Ph.D., MBA, President of Vyriad. "This reflects years of sustained effort from investigators, study staff, and the R&D and manufacturing teams here in Rochester. We are grateful to everyone who made it happen, and to the patients who choose to take part."

VV169 was developed using Vyriad’s proprietary in vivo lentiviral platform centered on blinded and retargeted VSV-G pseudotyping. To enable direct in vivo delivery, VV169 utilizes the targeted lentiviral vector to deliver a potent anti-BCMA CAR payload. Upon intravenous administration, the vehicle specifically targets and transduces T cells, enabling rapid generation of functional CAR T cells. This targeted approach results in highly specific payload expression and minimizes the risk of infusional toxicities.

"For patients with aggressive multiple myeloma, waiting weeks for a therapy to be manufactured can be a significant barrier," said Chief Scientific Officer Stephen Russell, M.D., Ph.D. "VV169 is designed to change that by creating CAR T cells directly inside the body, thereby making this off-the-shelf approach to CAR T more accessible for patients. We look forward to evaluating the potential of this program in the clinic."

The Phase 1 trial will evaluate the safety and initial efficacy signals of VV169 in up to 40 patients with relapsed/refractory multiple myeloma. The trial, conducted at Mayo Clinic by principal investigator Yi Lin, M.D., Ph.D., head of the center’s in vivo CAR T program, will have key primary objectives to assess overall safety, identify dose-limiting toxicities, and determine the recommended Phase 2 dose. The secondary objective will focus on assessing preliminary efficacy signals of VV169 and evaluating in vivo CAR T cell expansion and persistence.

For more information, including trial details and eligibility criteria, please visit the study page on clinicaltrials.gov (NCT07802717).

(Press release, Vyriad, SEP 14, 2026, View Source [SID1234670841])