Novel In Vivo CAR T Receives FDA Fast Track Designation

The FDA has granted fast track designation to UB-VV111 for the treatment of relapsed/refractory large B-cell lymphoma (LBCL) following 2 or more prior lines of therapy and relapsed/refractory chronic lymphocytic leukemia (CLL) following 2 or more prior lines of therapy.¹

“This fast track designation marks a key milestone in the advancement of in vivo CAR [chimeric antigen receptor] T-cell therapies,” said Luke Walker, MD, chief medical officer of Umoja Biopharma, in a news release. “UB-VV111 continues to lead the in vivo CAR T cell field in the US, 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.”

UB-VV111 is an investigational, off-the-shelf product that generates CD19-directed CAR T cells in vivo. This capability has the potential to address limitations with traditional ex vivo CAR T-cell therapy for patients and providers, including high costs, long wait times, limited product availability, and difficult treatment.

FDA fast track is a process intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill unmet medical needs.² This is determined by whether the drug will have an impact on survival or day-to-day function or can slow the progression of a disease to a more serious state. Drugs that receive fast track designation are eligible for more frequent meetings with the FDA, more frequent written communication from the FDA, eligibility for accelerated approval and priority review if relevant criteria are met, and rolling review.

A phase 1 trial (NCT06528301) is assessing the agent in relapsed/refractory CD19-positive B-cell malignancies.³ The study’s primary end point is incidence of adverse events, and the key secondary end point is overall response rate.

An estimated 106 patients are enrolled, and 8 sites across the US and Australia are recruiting. To be eligible for study enrollment, patients are required to have measurable disease according to Lugano 2014 criteria for LBCL or iwCLL 2018 criteria for CLL, no serious concomitant disease, an ECOG performance status of 0 or 1, and adequate organ function. Those who are pregnant or breastfeeding, have current isolated central nervous system involvement, have received allogeneic bone marrow transplant or cell therapy, or have systemic autoimmune disease or immunodeficiency (excluding controlled type 1 diabetes or thyroid disease) are not eligible for participation in the study.

The study has an estimated completion date of March 2029.

REFERENCES

1. Umoja Biopharma announces that UB-VV111 receives FDA fast track designation for relapsed/refractory B-cell malignancies. News release. Umoja Biopharma. September 30, 2025. Accessed October 1, 2025. https://tinyurl.com/ye2xkuay

2. Fast track. US FDA. Updated August 13, 2024. Accessed October 1, 2025. https://tinyurl.com/y748ywj9

3. A phase 1 study of UB-VV111 with and without rapamycin in relapsed/​refractory CD19+ B-cell malignancies. ClinicalTrials.gov. Updated July 15, 2025. Accessed October 1, 2025. https://clinicaltrials.gov/study/NCT06528301