Advancing Immunotherapy: Supporting A CAR T-Cell Therapy Study In Hematologic Malignancies

To address a life-threatening complication of immunotherapy in hematologic malignancies, a U.S. biotech company developed a novel compound. Their study, conducted across the U.S., employed an adaptive design encompassing Phase Ib dose-finding and Phase IIa randomized proof-of-concept stages. Faced with challenges such as difficulties in site identification and engagement, potential shortages in standard-of-care drug supplies, and a previously underprepared study team, the sponsor enlisted the comprehensive services of TFS HealthScience (TFS).

TFS addressed these challenges by assembling a project management team with pertinent experience, leveraging an established network of Phase I sites to enhance site engagement and recruitment efficiency, and implementing proactive contingency plans to mitigate drug supply shortages. This collaborative approach resulted in operational success, characterized by efficient site engagement, effective risk management, and thorough preparation of the study team.