CGCI clinical and translational researchers conduct multiple investigator-initiated and sponsored multi-center clinical trials. These include clinical trials of CAR-T, CAR-NK, NK, TCR-T, viral CTL, and TILs for the treatment of hematologic malignancies and solid tumors.
A dedicated group of talented clinical research associates and data coordinators are involved in conducting these trials.
The complicated nature of CGCI clinical trials requires comprehensive, multidisciplinary coordination. CGCI principle investigators, CRAs, data coordinators, and managers, including quality managers and medical directors for the Cellular Therapy Laboratory and Pheresis Center, regularly meet and review the status of all patients undergoing treatment at CGCI.
The team also reviews proposals for future clinical trials and oversees the start-up and inclusion of FDA-approved treatments. Standard procedures for workflow and transition of patients between different providers are established before opening a CGCI clinical trial to ensure seamless treatment for each patient enrolled in these trials.
The CGCI needs to approve clinical trials (Oncology and non-oncology) in which cells or genetically modified cells are actually infused into patients before these protocols are reviewed by IRB. Principal investigators should submit their protocols to the CGCI for review before IRB review. IBC review of these trials doesn’t need CGCI approval. These protocols include any of the following products that will be injected into humans here at WashU: CAR-T, TCR-T, Tumor-Infiltrating Lymphocytes (TIL), NK cell, Viral CTLs (e.g. EBV, CTL, CMV CTL, etc.) and Gene Therapies using vectors.