Umoja Biopharma Receives FDA Clearance to Begin Clinical Trial of UB-VV400 In Vivo CAR T Cell Therapy
Friday, July 17, 2026
Umoja Biopharma has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for UB-VV400, a CD22-directed in vivo CAR T cell therapy for adults with relapsed or refractory B-cell malignancies.
The investigational therapy is the company's second VivoVec™-based in vivo CAR T cell programme to advance into U.S. clinical trials. UB-VV400 is designed to generate CAR T cells directly within a patient's body, offering a potential alternative to conventional CAR T cell manufacturing.
Following the IND clearance, Umoja Biopharma plans to begin the Phase 1/2 VIBRANT-1 study at clinical sites across the United States. The first patient is expected to receive treatment during the third quarter of this year.
The open-label trial will include dose-escalation and expansion stages to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of UB-VV400 in combination with rapamycin in patients with relapsed or refractory B-cell malignancies.
The study has been designed to include patients whose disease has progressed following previous CAR T cell therapy, addressing an area of significant unmet medical need.
In addition, initial clinical data from an investigator-initiated trial of UB-VV400 in China is expected to be presented at a major medical conference during the second half of 2026.
Source: globenewswire.com
