Results:

As of July 21, 2025, 15 patients have enrolled in the study. Median age is 57 (34-82) years; 62% are male, 8% are Asian, and 62% are Hispanic/Latino. At a median follow-up of 12 (range 1-20) months, the overall response rate is 100%. Of the 13 evaluable patients, 11 have achieved stringent complete response (sCR) and had an MRD assessment, and all these individuals attained 10 -5 MRD-negativity (85%; 95% CI 54%- 98%); furthermore, MRD testing by clonoSEQ NGS confirms that all 11 patients attained 10 -6 MRDnegativity. The median time to MRD negativity was 7 (range 5-13) months. Among the remaining 2 patients, 1 has obtained sCR and is pending MRD assessment at the time of data cutoff (completed 3 cycles of treatment); 1 patient has a positive immunofixation IgG band (completed 4 cycles of treatment). Of the 13 enrolled patients, 12 required IVIG due to IgG levels <400 mg/L. Standard prophylaxis with antivirals and antibiotics were given to all patients per the study protocol. None of the patients had CRS or ICANS. There were 5 drug-related ≥ grade 3 adverse events (AEs) (3 neutropenia, 1 anemia, and 1 pneumonia). There were no serious AEs. To date, no patients have progressed to active MM nor have any died from any cause.

Discussion:

Here, we used a novel combination therapy with Dara/Tec with the goal of achieving high rates of sustained MRD negativity after a pre-defined duration of therapy (24 months). We were able to deliver very high rates of 10 -6 MRD-negativity in the setting of high-risk SMM (>80-90% of patients). No unexpected safety concerns were identified. At the meeting, we will present updated data on clinical efficacy including preliminary data on durability of MRD negative responses, i.e. sustained MRD negativity (clinicaltrials.gov NCT06100237).