Trial not recruting yet. At Rhode Island and Colorado.
I came across this weeks ago and I was hesitant to post, because CAR-T cells are serious business and this sounded new. BUT then, I remembered/ realized THIS trial is a quite well known trial on this forum. It was one of the first immunotherapies tried by patients with mainly liver mets, time ago, at the end of 2012 and 2013. It was usually referred for us at that time as the "Rhode Island liver trial" or "Designer T-Cells trial".
Back then, a couple of persons went for that trial, had CEA lowered, not bad permanent effects but (if memory serves me right) had more tumour burden in other areas and that precluded them from continue. I observe this concerning worries about safety.
The principal investigator is the same, Dr Steven Katz (Roger Williams, Rhode Island), who continued with other trials with CAR-T cells in the meantime. Probably they have refined this protocol a great deal, during these past years.
Three infusions of gene-modified anti-CEA T cells over the course of 3 weeks into the hepatic artery via a percutaneous approach along with low dose IL-2 (interleukin-2).
(anti-CEA CAR-T cells = Gene modified patient T cells = Designer T cells
Patients undergo leukapheresis from which peripheral blood mononuclear cells are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for CEA. Cells are expanded in culture and returned to the patient by percutaneous hepatic artery infusion at specific cell doses. Prior to the first dose, each patient will undergo diagnostic angiography to verify suitable arterial anatomy. Three anti-CEA CAR-T doses per patient are planned at 1-week intervals. Low dose interleukin-2 will be given via an ambulatory infusion pump for 4 weeks.
HITM-SURE: “A PHASE Ib TRIAL OF CAR-T HEPATIC ARTERY INFUSIONS DELIVERED WITH THE SUREFIRE INFUSION SYSTEM FOR CEA EXPRESSING LIVER METASTASES”
Principal Investigator: Dr. Steven C. Katz, MD, FACS
Tumor must be CEA-expressing demonstrated by elevated CEA level (CEA >10)
Liver metastases must be documented
Failed at least one line of conventional chemotherapy
Good performance status
http://www.weknowcancer.org/research/im ... -protocols
Old discussions on this forum, patients in that trial (well, the old version of that trial):
Other ongoing trial, same investigator, anti-CEA CAR-T cells + Sir-Spheres https://clinicaltrials.gov/ct2/show/NCT02416466