Celyad is ready to enroll patients in its Phase 1 THINK trial in Rosewell Park, N.Y. and the University of Pittsburgh Medical Center in Pennsylvania after gaining authorizing from the U.S. Food and Drug Administration (FDA) for the study in the U.S.
The multinational trial is evaluating NKR-2 CAR T-cells in five solid cancers and two hematological (blood) cancers. No toxic events have been reported in other patients enrolled in the study so far in Europe.
“The FDA approval for the THINK trial is an important milestone allowing us to initiate the THINK clinical trial in the USA. We are now looking forward to enrolling the first patients in both solid and hematological arms of the study in the U.S.,” Christian Homsy, CEO of Celyad, said in a news release.
CAR T-cells are a type of engineered immune cells that have shown tremendously good results in studies of other cancers. Researchers gather a patient’s own T-cells and add a gene that makes them better at recognizing and attacking the tumor. The cells are then injected back into the patient’s bloodstream.
While most CAR T-cell therapies recognize a unique cancer antigen, Celyad’s NKR-2 CAR T-cells express the human receptor NKG2D, which recognizes eight naturally occurring ligands that are overexpressed in more than 80 percent of tumors.
Preclinical studies have shown that NKR-2 CAR T-cells not only induce direct cancer cell death, they also destroy the tumor’s blood supply, inhibit the mechanisms that enable the tumor to evade immune surveillance, and activate other anti-tumor immune cells.
The Phase 1b THINK trial (NCT03018405) was designed to assess the safety and effectiveness of NKR-2 CAR T-cells in seven refractory cancers, including five solid tumors — bladder, colorectal, ovarian, pancreatic and triple-negative breast cancers — and two blood cancers — acute myeloid leukemia and multiple myeloma.
The open-label trial, which is already running in Belgium, will test the therapy at three dose levels adjusted to body weight in 24 patients. Each patient will receive three successive administrations of the selected dose, administered two weeks apart.
An extension phase of the trial will enroll an additional 86 patients.
“I would like to thank the team as well as our partners for the incredible work achieved so far to make the THINK trial progress at such a good pace,” said Jean-Pierre Latere, chief operating officer of Celyad. “In the coming months, all our efforts will be dedicated to the recruitment and follow-up of new patients for each dose-level cohort, but also to the opening of new clinical sites across the EU and the U.S.”