The U.S. arm of a Phase 1 clinical trial of Celyad as a solid-tumor treatment has kicked off with the dosing of the first ovarian cancer patient at the Roswell Park Cancer Institute in Buffalo, New York.
The THINK trial (NCT03018405) is in the midst of testing the second of three doses to determine an optimum level of Celyad.
Researchers are evaluating the safety and therapeutic activity of autologous Natural Killer Receptor-2 (NKR-2) T-cells in patients with different kinds of metastatic tumors, or ones that have spread. T-cells are a type of immune cell.
NKR-2 cells are a variation of the Chimeric Antigen Receptor (CAR) treatment approach, which involves inserting genes that code for NK receptors into T-cells. The T-cells then bind to ions or molecules in cancer cells known as ligands. Once binding occurs, the body recruits other immune cells to kill the cancer cells.
The five solid tumors in the study are ovarian, bladder, colorectal, pancreatic, and triple-negative breast cancer. It also includes two kinds of blood tumors: acute myeloid leukemia and multiple myeloma.
One pancreatic and two colorectal cancer patients have received the first dose level. They tolerated it without a major adverse event.
Researchers are adjusting doses for body weight. They administering each dose three times, once every two weeks. The team will examine Celvad’s therapeutic activity and adverse effects for 24 months. The estimated completion date of the trial is August 2020.
The dose-escalation stage will include up to 24 patients. An extension stage will include up to 86 additional patients.
“NKR-2 represents a unique approach to CAR T-cell therapy, and we hope that our efforts help to establish a new treatment option that will benefit many people with cancer,” Dr. Kunle Odunsi, deputy director of the THINK trial research team at Roswell Park, said in a press release.
“Preliminary results from the first dose-level are encouraging, further reinforcing the favorable safety profile of NKR-2,” said Dr. Frédéric Lehmann, vice president of immuno-oncology at Celyad. “The THINK study is progressing very well, and we look forward to the completion of the dose-escalation stage of the trial and the initiation of the expansion segments to confirm the encouraging clinical signal seen in our previous phase 1 study.”