Clinical Research and Patient Care
Since its inception in 2017, CCT has created a state-of-the-art clinical trial infrastructure to ensure the highest levels of Good Clinical Practice compliance, employ individuals with deep expertise in regulatory requirements for cellular therapeutics, and launch an electronic data capture system for toxicity monitoring.
Under the leadership of David Miklos MD, PhD, Clinical Director of the CCT, we have treated many hundreds of cancer patients with cell therapies. We have launched cancer cell therapy trials for B cell malignancies and solid tumors. Among these many studies, our highest priorities and major costs are associated with investigator-initiated trials, wherein we deliver a novel therapy developed by Stanford researchers that is typically not available at any other institution.
Investigator-Initiated Clinical Trials
Bispecific CD19-22 Investigator-Initiated Trials
Two active investigator-initiated trials are testing a novel loop CAR molecule that contains targeting motifs against both CD19 and CD22, with the goal of diminishing tumor recurrence due to target loss. Initially, Stanford was the only center offering a multi-specific CAR-T cell trial for lymphoma, and now dozens of trials are taking place around the world.
Monospecific CD22-CAR Investigator Initiated Trials
We are also conducting two investigator-initiated trials testing a monospecific CD22-CAR developed in the Mackall lab at NIH for leukemia and lymphoma in children and adults. Stanford has been granted a breakthrough therapy designation by the FDA. The treatment is not available at any other academic medical center.
GD2 Investigator Initiated Trial in Solid Tumors
In 2020, we launched our first investigator-initiated trial targeting solid tumors. This study builds upon collaborative work undertaken with Michelle Monje, MD, PhD wherein we demonstrated activity of GD2-CAR T cells for a lethal pediatric brain tumor—diffuse intrinsic pontine glioma, published in Nature Medicine in 2018. As of December 2020, we have treated four patients and have seen promising results.