Gamida Cell is enrolling participants in a Phase 1 clinical trial of an immunotherapy for myeloma and non-Hodgkin’s lymphoma that is based on expanding the number of the body’s natural killer cells to fight the cancers.
The study (NCT03019666) will assess the safety and preliminary effectiveness of the treatment in 24 patients with relapsed or refractory multiple myeloma or non-Hodgkin’s lymphoma that contains CD20 proteins. Gamida calls its approach NAM-expanded natural killer cells, or NAM-NK cells, because it involves increasing these cells.
“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 and oncologist at University of Minnesota Health, said in a press release. Bachanova is lead investigator of the Phase 1 trial at the university’s Masonic Cancer Center.
“We initiated this phase 1 study based on encouraging preclinical [trial] data to bring a potential immunotherapeutic treatment approach to patients with these life-threatening cancers,” she said.
The study’s primary objective is to determine the maximum dose of NAM-NK cells that patients can tolerate. Secondary endpoints include seeing how many patients respond to the treatment and determining its toxicity.
Participants will first undergo a round of chemotherapy with cyclophosphamide and fludarabine to eliminate diseased white blood cells. Then they will receive two doses of NAM-NK cells followed by a short course of interleukin-2 (IL-2). IL-2 will be used to enhance the survival and expansion of NAM-NK cells.
Multiple myeloma patients will receive Empliciti (elotuzumab), a monoclonal antibody approved for treating the disease, before and after NAM-NK cells — to boost immune response against the tumor.
Natural killer cells are key immune cells in the fight against tumors. But their insufficient numbers and their short lifespan have limited their applicability as a treatment.
Using its NAM technology, Gamida can increase the number of NK cells. They have displayed superior lifespan, proliferation, and ability to infiltrate into multiple organs when tested in animal models, the company said on its website.
In addition, NAM NK cells are particularly good at secreting factors that recruit other immune cells into tumors, amplifying their anti-tumor effect.
“NAM-expanded NK cells have demonstrated increased killing potential and increased in vivo [living-organism] persistence and proliferation in preclinical [trial] studies,” said Tony Peled, the chief scientific officer at Gamida Cell. “We are pleased to see the NAM-NK Cell program enter clinical testing and are committed to collaborating with Dr. Bachanova and her team at the Masonic Cancer Center.”