Gamida Cell is enrolling participants in a Phase 1 clinical trial of its natural killer cell treatment for adults with relapsed or refractory non-Hodgkin’s lymphoma and multiple myeloma.
The trial (NCT03019666) at the Masonic Cancer Center, University of Minnesota, will include 24 patients aged 18 to 70.
Gamida’s therapy is called NAM-expanded natural killer cells. It is based on increasing the number of immune killer cells that can fight cancer by exposing them to a small molecule called nicotinamide, or NAM.
To enroll in the trial, non-Hodgkin lymphoma patients must have immune B-cells with CD20 protein and must have failed conventional therapy. Myeloma patients must have received two previous lines of therapy.
“There is significant need for novel therapeutic approaches for refractory non-Hodgkin lymphoma and multiple myeloma, which are aggressive malignancies with limited treatment options,” Veronika Bachanova, a hematologist at University of Minnesota Health, said in a press release. “We initiated this Phase 1 study based on encouraging preclinical data to bring a potential immunotherapeutic treatment approach to patients with these life-threatening cancers,” added Bachanova, the trial’s lead investigator.
Natural killer cells are key players in the fight against tumors. But their insufficient numbers and short lifespan have limited their applicability as a treatment.
Using its NAM technology, Gamida increases the number of natural killer cells by exposing them to nicotinamide. The tweaked cells lived longer and multiplied faster in animal tests, and were able to infiltrate multiple organs, the company said on its website.
In addition, NAM-expanded natural killer cells generate higher levels of inflammatory proteins known as cytokines, Gamida said. They are particularly good at recruiting other immune cells into tumors to amplify their tumor-killing ability, it said.
Before receiving NAM cells, patients must first have a round of cyclophosphamide and fludarabine chemotherapy to deplete their body of immune cells, including diseased ones.
Then they receive two doses of NAM cells and a short course of interleukin-2 to promote the killer cells’ expansion.
To help facilitate the expanded killer cells’ toxic effect, lymphoma patients will receive Rituxan (rituximab) before and after they get the cells. Myeloma patients will receive Empliciti (elotuzumab) instead of Rituxan.
The trial’s primary goal is to assess the maximum level of the treatment that patients can tolerate. Secondary objectives include seeing how many patients respond to the treatment and how long it takes before their disease progresses. Researchers will also study the treatment’s toxicity.
“NAM-expanded NK [natural killer] cells have demonstrated increased killing potential” and increased life span and proliferation in animal studies, said Tony Peled, Gamida Cell’s chief scientific officer. “We are pleased to see the NAM-NK Cell program enter clinical [trial] testing and are committed to collaborating with Dr. Bachanova and her team at the Masonic Cancer Center.”
You can learn more about the trial at the Masonic Cancer Center website or the trial’s registry page.
