FDA Grants Fast Track to UB-VV111 for B-Cell Blood Cancers

The U.S. Food and Drug Administration (FDA) has granted fast track designation to UB-VV111 for the treatment of relapsed/refractory large B-cell lymphoma following two or more lines of prior therapy and relapsed/refractory chronic lymphocytic leukemia following two or more lines of prior therapy, according to a news release from Umoja Biopharma.

“This fast track designation marks a key milestone in the advancement of in vivo CAR-T cell therapies,” Dr. Luke Walker, Chief Medical Officer of Umoja Biopharma, said in the news release. “UB-VV111 continues to lead the in vivo CAR-T cell field in the U.S., and today’s announcement further reinforces its potential to address unmet needs in the treatment of those living with relapsed/refractory B-cell malignancies. This achievement is a testament to the dedication of our clinical trial sites and to the patients who inspire our mission every day.”

An early-stage clinical trial is testing UB-VV111 for safety and antitumor activity in CD19-positive B-cell cancers. In 2024, UB-VV111 became the first in vivo CAR-T cell therapy cleared by the FDA for study. AbbVie holds an exclusive option to license Umoja’s CD19-targeted in vivo CAR T-cell therapy candidates, including UB-VV111.

UB-VV111 is an investigational off-the-shelf treatment designed to create CD19-directed CAR-T cells inside the body. This approach may help overcome challenges seen with traditional CAR-T cell therapies made outside the body, such as high costs, long manufacturing times, complex treatment steps and limited availability for patients.

Relapsed or refractory large B-cell lymphoma is a type of non-Hodgkin lymphoma that starts in B-cells, a kind of white blood cell. Relapsed means the cancer has come back or not responded to treatment. This diagnosis applies to disease that has returned or not improved after two or more previous treatments.

Relapsed or refractory chronic lymphocytic leukemia is a slow-growing cancer of the blood and bone marrow that also affects B cells. It describes disease that has persisted or come back after two or more prior therapies.

More on the Phase 1 Trial

The phase 1 clinical trial is testing UB-VV111. The goal of the study is to find a safe dose and understand how well the treatment works against cancer.

Participants will receive UB-VV111 together with rapamycin. This early-phase, open-label study plans to include about 106 patients and began in March 2025. It is expected to be completed by March 2029.

To join, participants must be at least 18 years old, have measurable disease, good organ function and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 — a scale doctors use to measure how well a patient can perform daily activities. A score of 0 means the person is fully active, while 1 means they have some symptoms but can still carry out light or sedentary work.

Patients who previously received CD19-directed therapy must have confirmation that their cancer still expresses CD19. People cannot join if they are pregnant or breastfeeding, have active infections such as HIV or hepatitis B or C, current central nervous system involvement, or serious health conditions like uncontrolled heart disease.

This study is currently recruiting at multiple sites across the United States and Australia, including City of Hope in California, the University of Chicago, Washington University in Missouri, the University of Nebraska, the University of Cincinnati, Fred Hutch Cancer Center in Washington, Royal North Shore Hospital in New South Wales and St. Vincent’s Hospital Melbourne in Victoria.

Reference

1. “Umoja Biopharma Announces that UB-VV111 Receives FDA Fast Track Designation for Relapsed/Refractory B-Cell Malignancies.” Umoja Biopharma. Sep. 30, 2025.

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