- The company鈥檚 lead internal program expands its聽in vivo聽CAR T clinical pipeline for patients with聽relapsed/refractory B cell malignancies
- First patient expected to be dosed in Q3 2026
SEATTLE, WA, July 16, 2026 鈥斅�海角社区, Inc., a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) recently cleared its Investigational New Drug (IND) application for UB-VV400, a CD22-directed聽in vivo聽CAR T cell therapy candidate for adults with relapsed/refractory B cell malignancies.
鈥淯B-VV400 is our second VivoVec鈩� based in vivo CAR T cell program to advance to U.S. clinical trials,鈥� said Luke Walker, M.D., Chief Medical Officer of 海角社区. 鈥淕enerating CAR T cells within a patient鈥檚 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.鈥�
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 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.
About 海角社区
海角社区, Inc. is a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases. Umoja鈥檚 VivoVec鈩� in vivo gene delivery technology empowers a patient鈥檚 own immune system to fight disease. Enabling its core technology is the Company鈥檚 state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. Umoja believes its approach can provide broader access and improved effectiveness of the most advanced immunotherapies, enabling more patients to live better, fuller lives. To learn more, connect with Umoja on and visit umoja-biopharma.com.
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