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# Umoja Bio Wins Fast Track for B-Cell Malignancies Drug
- URL: https://www.fdaweb.com/umoja-bio-wins-fast-track-for-b-cell-malignancies-drug/
- Published: 2025-10-01T12:00:00.000Z
- Updated: 2026-09-14T15:23:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159972

FDA has granted Umoja Biopharma a fast track designation for its investigational therapy UB-VV111 for treating relapsed or refractory Large B-cell Lymphoma and Chronic Lymphocytic Leukemia following two or more prior therapies. The company describes UB-VV111 as an off-the-shelf, *in vivo* CAR T cell therapy designed to generate CD19-directed CAR T cells directly inside patients. The approach aims to overcome several limitations of traditional autologous CAR T cell therapies, including high manufacturing costs, long wait times, complex treatment processes, and limited product availability, it says.

The therapy is currently being evaluated in a Phase 1 clinical trial (NCT06528301) for safety and antitumor activity in patients with CD19-positive B-cell malignancies. AbbVie retains an exclusive option to license Umoja’s CD19-directed in vivo CAR T cell therapy candidates, including UB-VV111, the company says.