The novel drug, IDP-023, is being investigated in patients with relapsed or refractory non-Hodgkin lymphoma or multiple myeloma.
A phase 1 trial recently kicked off evaluating the novel drug, IDP-023 for the treatment of patients with relapsed or refractory multiple myeloma and non-Hodgkin lymphoma, according to a news release issued by Indapta Therapeutics, the manufacturer of the drug.
So far, two patients at The University of Texas MD Anderson Cancer Center have started treatment on the trial: one received a single dose of IDP-023, while the other received the first of three planned doses. According to the release, the researchers plan on enrolling subsequent cohorts of patients who will receive three doses of IDP-023 with or without interleukin-2.
The early stage (the phase 1 escalation phase) of the trial will determine the safety of multiple doses of the drug given in combination with interleukin-2. Researchers will look at the incidence of side effects and dose-limiting toxicities.
Once the optimum dosage is established, the phase 2 expansion of the drug will be tested in combination with the monoclonal antibodies Rituxan (rituximab) and Darzalex (daratumumab). The main goals of the phase 2 portion of the study vary based on the disease type.
For patients with multiple myeloma, the primary outcomes are anti-tumor activity, as measured by the objective response rate (percentage of patients whose disease shrinks or disappears from treatment); complete response rate (percentage of patients whose disease disappears); stringent complete response; very good partial response; and partial response.
The primary outcome for the non-Hodgkin lymphoma group is anti-tumor activity as determined by objective response rate
In both cohorts, the researchers will also be analyzing how the drug moves throughout the body, how it interacts with the body and the incidence of side effects.
Researchers are hoping to recruit 128 patients to participate in the trial, which will be conducted at the University of Minnesota, The University of Texas MD Anderson Cancer Center and NEXT Oncology Virginia.
To be eligible, patients with multiple myeloma must require systemic treatment and have relapsed/refractory disease after three or more prior lines of therapy. Patients with non-Hodgkin lymphoma must have undergone two or more lines of systemic chemotherapy. All participants must have an ECOG performance status of 0 or 1, indicating that they can perform all or most of their daily tasks independently, and have a life expectancy of 12 weeks or longer, as determined by the investigator.
IDP-023 is a natural killer (NK) cell therapy, which, according to research published in the Journal of Translational Medicine, are engineered cell therapies that have the potential to eradicate a large number of nearby cancer cells. The National Institutes of Health defines NK cells as, “effector lymphocytes of the innate immune system that control several types of tumors and microbial infections by limiting their spread and subsequent tissue damage.”
The novel drug is an “off-the-shelf” NK cell therapy, meaning that it is engineered with healthy donor cells, unlike other similar therapies, such as many CAR-T cell therapies, that re-engineer the patient’s own immune T cells to find and fight cancer.
“Based on the encouraging clinical activity of NK cells demonstrated by others and the superior activity of IDP-023 compared to conventional NK cells in preclinical models, we are looking forward to evaluating the safety and clinical activity of IDP-023 in this phase 1 trial,” Dr. Mark Frohlich, CEO of Indapta, said in the news release.
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