Umoja Biopharma Wins FDA IND Clearance for First CD22-Directed In Vivo CAR T Therapy

Umoja Biopharma announced that the FDA has cleared its Investigational New Drug (IND) application for UB-VV400, a CD22-directed in vivo CAR T-cell therapy candidate for adults with relapsed or refractory B-cell malignancies. The company describes UB-VV400 as the industry's first known CD22-directed in vivo CAR T therapy, and it marks Umoja's second VivoVec-based in vivo CAR T program to reach US clinical trials, following its CD19-directed UB-VV111 program.

Luke Walker, MD, chief medical officer of Umoja Biopharma, said in a press release, "Generating CAR T cells within a patient's body would have the potential to transform clinical practice. We designed this phase 1/2 trial to address a critical, real-world unmet need for patients, including those who have progressed after prior CAR T cell treatment."

How does in vivo CAR T generation work?

Conventional CAR T therapy requires collecting a patient's T cells through leukapheresis, genetically modifying them outside the body, expanding the modified cells, and reinfusing them after chemotherapy-based lymphodepletion, a process that typically takes weeks and involves substantial manufacturing complexity and cost. In vivo CAR T approaches like Umoja's VivoVec platform aim to bypass that entire ex vivo manufacturing process by using a retargeted lentiviral vector to deliver the CAR transgene directly to T cells while they remain inside the patient's body, with the intent of generating CAR T cells in situ rather than in a lab.

UB-VV400 specifically targets CD22, a cell surface marker expressed on B-cell malignancies, offering an alternative target to the CD19-directed approaches that dominate the current CAR T landscape, including Umoja's own UB-VV111 program. That distinction matters clinically: CD22-directed therapy is being positioned in part for patients who have already progressed after prior CD19-directed CAR T treatment, a population with CD19-negative or CD19-low relapse where a differently targeted CAR could still be effective.

How does this fit the broader in vivo CAR T field?

Umoja is one of several companies racing to bring in vivo-generated CAR T therapies into the clinic, using different delivery technologies to achieve the same underlying goal of eliminating ex vivo manufacturing. Some competing approaches use targeted lipid nanoparticles rather than lentiviral vectors to deliver CAR-encoding genetic material directly to T cells, an alternative delivery strategy that has also shown early preclinical promise in dual-targeting constructs directed at both CD19 and CD22. Regardless of delivery vehicle, all of these approaches share the same underlying rationale: reducing the logistical burden, cost, and lymphodepletion requirements associated with today's ex vivo CAR T manufacturing model.

Initial clinical data from an investigator-initiated trial of UB-VV400 already underway in China is expected to be shared at a major medical meeting in the second half of 2026, which will likely offer the first real-world look at how the CD22-directed in vivo approach performs before the newly cleared US trial generates its own data.

What happens next?

With IND clearance secured, Umoja will move UB-VV400 into a Phase 1/2 trial in the US, evaluating both oncology and, per the company's broader pipeline positioning, potential autoimmune disease applications for CD22-directed in vivo CAR T therapy. The parallel China investigator-initiated trial and upcoming US study will together shape how quickly Umoja can generate the clinical evidence needed to validate in vivo CAR T generation as a viable alternative to today's ex vivo standard.

References

1. Umoja Biopharma Announces FDA Clearance of IND Application for UB-VV400, the Industry's First Known CD22-Directed In Vivo CAR T Cell Therapy for Relapsed/Refractory B Cell Malignancies. (2026 Jul 16). GlobeNewswire. https://www.globenewswire.com/news-release/2026/07/16/3328378/0/en/umoja-biopharma-announces-fda-clearance-of-ind-application-for-ub-vv400-the-industry-s-first-known-cd22-directed-in-vivo-car-t-cell-therapy-for-relapsed-refractory-b-cell-malignanc.html
2. Lavery P. (2025 Aug 6). NanoCell's LNP Platform Shows Promise for In-Vivo CAR-T Development. BioPharm International. https://www.biopharminternational.com/view/nanocell-lnp-platform-shows-promise-in-vivo-car-t-development
3. Yin B et al. (2023 Mar 1). Tactics and Strategies for Designing an Ideal Lentiviral Vector Platform. BioPharm International. https://www.biopharminternational.com/view/tactics-and-strategies-for-designing-an-ideal-lentiviral-vector-platform