Efficacy
deaths
Efficacy was determined as best response until visit 10 (day 90). In total, 20 (65%) of 31 patients experienced reduction in MRD in BM as defined as any reduction compared to baseline (Fig. Waterfall plot showing MRD change after FLYSYN treatment. Waterfall plot of the best response after baseline (maximum change of MRD level from baseline) until visit 10 (up to 90 days after first FYSYN application). All dose cohorts are displayed. Six patients were MRD negative, and five patients (asterisk) had a MRD reduction of ≥ 1 log compared to MRD levels prior to FLYSYN treatment. MRD was measured with qPCR or NGS, depending on MRD marker. Seven patients (dagger) did not respond to FLYSYN and had MRD increase > 100%. MRD, minimal residual diseaseAcross the study, median time to MRD response was 29 days (range 15–92). For cohorts 1–4, median time to MRD response was 29 days (range 15–43), whereas in cohorts 5 and 6, MRD response occurred 50.5 days (range 15–92) after FLYSYN treatment. Median time to progression for all treated patients was 6.9 months (95%, CI 3 months–not reached; 0 deaths) (Additional file 