ST. LOUIS, March 20, 2025 – Wugen, Inc., a clinical-stage biotechnology company focused on allogeneic, off-the-shelf cell therapies, has announced the initiation of its pivotal Phase 2 study evaluating WU-CART-007, a potential first-in-class, investigational CAR-T cell therapy targeting CD7 for pediatric and adult patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia (T-ALL) or T cell lymphoblastic lymphoma (T-LBL).
The decision to move into this pivotal trial was supported by previously reported positive data from Wugen’s Phase 1/2 study on WU-CART-007, which demonstrated clinically manageable safety and promising anti-leukemic activity, including a 91% overall response rate and a 73% composite complete remission rate in heavily pretreated R/R T-ALL/LBL patients. These results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2024 and the European Hematology Association (EHA) Hybrid Congress in June 2024.
WU-CART-007 has received significant regulatory support, including Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA),
https://www.globenewswire.com/news-release/2025/03/20/3046089/0/en/Wugen-Announces-Dosing-of-First-Patients-in-Pivotal-Trial-of-Off-the-Shelf-Allogeneic-CD7-Targeted-CAR-T-Cell-Therapy-WU-CART-007.html#:~:text=%22It’s%20been%2020%20years%20since,remain%20challenging%20hematologic%20malignancies%20with
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