The world’s first clinical trial for CAR T-cell therapy in neuroendocrine tumors has advanced to a higher dose level, an indication of progress. Advancing to what Chimeric Therapeutics calls Dose Level Two is possible because there were no safety concerns or “off-target” effects seen at the initial lower dose of the therapy.
The trial of CDM CDH17, a T-cell therapy developed at the University of Pennsylvania by Dr Xianxin Hua, targets an antigen expressed on the surface of cancer cells in neuroendocrine tumors and some other gastrointestinal cancers. NETRF funded the preclinical work beginning in 2014 to bring this innovative treatment from the bench to the clinic. Chimeric Therapeutics developed the clinical trial, which includes patients with intestinal neuroendocrine tumors, advanced colorectal cancer, and some gastric cancers.
Chimeric Therapeutics has reported early signs of efficacy of CDM CDH17. One patient who received the higher dose has stable disease and had 12% tumor shrinkage at their first scan post-treatment. The first NET patient to receive the initial, lower dose of cells had stable disease for 150 days. These are preliminary results, and results from more patients are needed to fully evaluate the treatment. “This is great progress, we can see the cells are hard at work; we’re looking forward to more data,” says Dr Rebecca McQualter, CEO of Chimeric.
In June, CDM CDH17 was granted Fast Track Designation by the Food and Drug Administration, which could streamline the review and development of this potential new treatment. In addition to the University of Pennsylvania, the trial is open at Sarah Cannon Research Institute in Nashville, Winship Cancer Center at Emory University, and the University of Chicago.