Lisata Therapeutics, Inc. announced the early completion of enrollment in its Phase 2a BOLSTER trial evaluating certepetide (formerly LSTA1), Lisata?s investigational product, as a treatment for first-line cholangiocarcinoma (CCA). This key milestone comes nearly six months sooner than originally expected. The BOLSTER trial is a Phase 2a double-blind, placebo-controlled, multi-center, randomized study evaluating certepetide in combination with standard-of-care (gemcitabine/cisplatin/durvalumab) versus standard-of-care alone in patients with first-line CCA in the United States.

The rapid enrollment of this cohort underscores the urgent need for new treatment options for patients with CCA, a difficult-to-treat solid tumor with a poor prognosis. Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in second-line CCA, Lisata has added an arm to the BOLSTER trial evaluating second-line CCA. The Company expects to enroll the first patient in the second-line CCA arm by the fourth quarter of 2024.