In a first-in-human study, IDP-023 demonstrated a promising safety and efficacy profile in patients with relapsed or refractory multiple myeloma, according to findings presented as a late-breaking poster by Krina Patel, MD, of the University of Texas MD Anderson Cancer Center at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
The open-label, phase 1/2, dose-escalation and expansion study evaluated adult patients who received IDP-023 as a single agent or in combination with or without interleukin-2 (IL-2) and with or without a CD38 monoclonal antibody (isatuximab, daratumumab, or rituximab).
As of September 22, 2025, 22 patients (median age, 68 years; range, 56–77) had been treated across three dose cohorts: 5×10⁹ (n=12), 10×10⁹ (n=7), and 20×10⁹ (n=3). The median number of prior therapies was six (range, 2–17), and half of patients had received a prior BCMA-targeted therapy, including CAR T-cell therapy.
No dose-limiting toxicities were observed through the maximum administered dose. None of the patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), grade 3 or higher cytokine release syndrome (CRS), bleeding events or infections. There were no treatment-related discontinuations or deaths. Investigators noted the safety profile of IDP-023 supports outpatient administration.
Overall, 18 patients (82%) experienced grade 3 or higher treatment-emergent adverse events, none of which led to treatment discontinuation. Deep responses, including very good partial responses or better, were reported across risk categories in this heavily pretreated population. Follow-up is ongoing, and updated efficacy data and the recommended phase 2 dose in combination with a CD38 monoclonal antibody will be reported, according to the researchers.
Reference
Patel K, Berz D, Gandhi M. IDP-023 allogeneic g-NK-cells +/- anti-CD38 monoclonal antibody for the treatment of relapsed/refractory multiple myeloma: Safety, efficacy and determination of recommended phase 2 dose. Abstract 1322. Presented at 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting. November 5–9; National Harbor, MD.
