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

On July 16, 2026 Umoja Biopharma, Inc., a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) recently cleared its Investigational New Drug (IND) application for UB-VV400, a CD22-directed in vivo CAR T cell therapy candidate for adults with relapsed/refractory B cell malignancies.

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"UB-VV400 is our second VivoVec based in vivo CAR T cell program to advance to U.S. clinical trials," said Luke Walker, M.D., Chief Medical Officer of Umoja Biopharma. "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. We remain highly encouraged by the early clinical activity and safety profile seen in the patients treated in our investigator-initiated trial of UB-VV400, and we look forward to sharing initial clinical data."

The Phase 1/2 VIBRANT-1 study of UB-VV400 will open soon at U.S. clinical sites, with the first patient anticipated to be dosed in Q3 this year. The open-label, dose escalation and expansion trial is designed to evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, and preliminary antitumor activity of UB-VV400 in combination with rapamycin in patients with relapsed/refractory B cell malignancies.

Initial clinical data from the investigator-initiated trial of UB-VV400 in China is expected to be shared at a major medical meeting in the second half of 2026.

(Press release, Umoja Biopharma, JUL 16, 2026, View Source [SID1234669277])