UB-VV111: First In Vivo CAR T Candidate Moves Forward With FDA Fast Track Designation

Umoja Biopharma announced that its investigational therapy, UB-VV111, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL) in patients who have progressed after at least 2 prior lines of therapy.¹ This milestone highlights the potential of a novel in vivo chimeric antigen receptor T-cell (CAR T) approach designed to overcome manufacturing and logistical barriers associated with conventional CAR T therapies.

“This fast track designation marks a key milestone in the advancement of in vivo CAR T-cell therapies,” Luke Walker, MD, chief medical officer of Umoja Biopharma, the developer of UB-VV111, stated in a news release. “UB-VV111 continues to lead the in vivo CAR T-cell field in the United States, 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.”¹

Traditional CAR T-cell therapy requires multiple complex steps: leukapheresis to collect patient T cells, ex vivo genetic engineering, expansion under controlled conditions, and reinfusion back into the patient. These processes can take several weeks, may not be feasible for patients with rapidly progressing disease, and require specialized infrastructure.

UB-VV111 neurodegeneration is a product that intends to make healing more straightforward. Its framework is VivoVec-Umoja’s cutting-edge platform. As a result, the therapy would in principle reprogram the patient's T cells only; therefore, there would be no need to take T cells outside the body, modify them, and then return them, basically allowing those who were not eligible for CAR T therapy to be treated.² Essentially, UB-VV111 aims to reduce manufacturing complexity and shorten treatment waiting times; hence, a more ample solution for patients with B-cell malignancies would be the easy accessibility and availability of this therapy.

In July 2024, the FDA cleared Umoja’s Investigational New Drug (IND) application for UB-VV111, enabling initiation of a first-in-human clinical trial.² According to the company, this represents the first in vivo CAR T candidate to reach the U.S. clinical stage. The study, known as INVICTA-1 (NCT06528301)³ is a phase 1 multicenter, open-label, dose-escalation trial designed to assess the intravenous and intranodal administration of UB-VV111, either combined with or without the use of rapamycin as an adjunct.⁴

The INVICTA-1 study is enrolling patients with relapsed/refractory LBCL and CLL, among those who have not undergone CAR T therapy as well as those who have received CAR T therapy.³ The study will implement the conventional 3+3 dose-escalation design for several arms, where separate dose escalations will be conducted for intravenous versus intranodal delivery, and for rapamycin co-administration and non-coadministration arms.⁴

UB-VV111 moving forward to human trials is a crucial moment in the development of cellular immunotherapy. Although many obstacles persist, such as making transduction more uniform, reducing the targeting of non-intended cells, and handling problems like cytokine release syndrome, this initiative exemplifies the expanding creativity of the CAR T domain.

If UB-VV111 advances successfully through clinical trials, pharmacists will be instrumental in the process of safety oversight, patient education, and the administration of such therapies into the collaborative care team.

REFERENCES

1. Brueck B. Umoja Biopharma Announces that UB-VV111 Receives FDA Fast Track Designation for Relapsed/Refractory B-Cell Malignancies | Umoja Biopharma. Umoja-biopharma.com. Published September 30, 2025. Accessed September 30, 2025. https://www.umoja-biopharma.com/news/umoja-biopharma-announces-that-ub-vv111-receives-fda-fast-track-designation-for-relapsed-refractory-b-cell-malignancies/

2. Umoja Biopharma Announces FDA Clearance of IND Application for UB-VV111, a CD19 Directed in situ CAR T for Hematologic Malignancies | Umoja Biopharma. Umoja-biopharma.com. Published July 31, 2024. https://www.umoja-biopharma.com/news/umoja-biopharma-announces-fda-clearance-of-ind-application-for-ub-vv111-a-cd19-directed-in-situ-car-t-for-hematologic-malignancies/

3. A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/​Refractory CD19+ B-cell Malignancies. Clinicaltrials.gov. Published June 7, 2025. Accessed September 30, 2025. https://clinicaltrials.gov/study/NCT06528301

4. Garcia JR. A phase I, multicenter, open-label study of UB-VV111 in combination with rapamycin in relapsed/refractory CD19+ B-cell malignancies. Journal of Clinical Oncology. 2025;43(16_suppl). doi:10.1200/jco.2025.43.16_suppl.tps2681