July 16, 2026 —
Umoja Biopharma announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for UB-VV400, a CD22-directed in vivo CAR-T cell therapy candidate for adults with relapsed or refractory B-cell malignancies.
UB-VV400 is built on Umoja’s VivoVec lentiviral platform and is designed to generate CAR-T cells directly inside a patient’s body. Umoja describes the program as the industry’s first known CD22-directed in vivo CAR-T therapy and the company’s second VivoVec-based in vivo CAR-T program to reach U.S. clinical trials, following its CD19-directed UB-VV111 program.
Conventional CAR-T therapy requires collecting a patient’s T cells through leukapheresis, genetically modifying them outside the body, expanding the engineered cells, and reinfusing them after lymphodepleting chemotherapy. This process can take weeks and involves substantial manufacturing complexity, logistics, and cost.
In contrast, in vivo CAR-T approaches aim to bypass ex vivo manufacturing by delivering the CAR genetic payload directly to T cells inside the patient. Umoja’s VivoVec platform uses a retargeted lentiviral vector to deliver the CAR transgene to T cells in vivo, with the goal of generating functional CAR-T cells within the body rather than in a manufacturing facility.
UB-VV400 targets CD22, a cell surface marker expressed on B-cell malignancies. This provides an alternative to CD19-directed CAR-T therapies, which dominate the current B-cell malignancy treatment landscape. The CD22 target may be particularly relevant for patients who relapse after prior CD19-directed CAR-T therapy, including cases involving CD19-negative or CD19-low disease.
The upcoming U.S. Phase 1/2 trial will evaluate UB-VV400 in adults with relapsed or refractory B-cell malignancies. Umoja has also indicated broader interest in exploring CD22-directed in vivo CAR-T approaches beyond oncology, including potential autoimmune disease applications.
Initial clinical data from an investigator-initiated trial of UB-VV400 already underway in China are expected to be presented at a major medical meeting in the second half of 2026. These data may provide an early view of the program’s clinical activity and safety profile before results emerge from the newly cleared U.S. study.
Umoja is part of a growing field of companies pursuing in vivo CAR-T generation using different delivery technologies, including retargeted lentiviral vectors and targeted lipid nanoparticles. The shared goal is to simplify cell therapy by reducing the need for centralized manufacturing, lowering logistical barriers, and potentially expanding patient access.
If successful, UB-VV400 could help validate a new model for in vivo cell therapy, where CAR-T cells are generated directly in patients and redirected against clinically important targets such as CD22. The program also expands the in vivo CAR-T field beyond CD19 and into post-CAR-T relapse settings where new treatment options remain urgently needed.
