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Early risk identification and comprehensive quality management plan ensured best possible outcome.

SITUATION

Neoantigen vaccines have appeared only recently as emergent immunotherapy and show great promise. Biopharmaceutical companies developing these drugs often have few resources and no experience in conducting the unique and complex clinical trials associated with cell and gene therapies (CGT)—which are very different from those conducted for traditional drug therapies. With limited patient populations, manufacturing issues, novel medical procedures and specialized equipment, these studies offer multiple challenges. Success requires critical efficiency, accuracy and safety measures.

George Clinical was contracted by a Biotech company to conduct a Neoantigen Vaccine for Solid Tumor study in China and provided study strategy, Quality Management System (QMS) setup, clinical operations and vendor oversight. With our experienced CGT team and over 20 years of trial experience in China, we were a good fit to ensure the best possible outcome for this CGT trial.

CHALLENGES

Protocol standardizations were lacking as well as clearly established standards for conducting apheresis of Peripheral Blood Mononuclear Cell (PBMC), identification techniques of neoantigen, optimum dosing regimen and evaluation of cellular immune response. Critical quality control issues around the cumbersome and timeconsuming neoantigen production process (10–12 weeks) required careful attention. Recruitment difficulties included a high screen failure rate and an insufficient target patient pool due to a very stringent protocol. The study timeline was being…