RE: Is P3 the key to it.30 Aug 2025 18:01
Interesting the data they will already have now on efficacy:
Outcome Measure Measure Description Time Frame
Estimate the efficacy of HG-CT-1 cells as defined by clinical response according to established criteria for AML. Proportion of subjects with response, according to ELN 2022 criteria. {Dohner et al., 2022 #29518}. To demonstrate the anti-AML activity of HG-CT-1. Day 14, Day 28, Month 3, Month 6 and Month 12
Estimate the Overall Survival (OS). Proportion of subjects alive at 6 months and one year. To demonstrate effect on disease biology and prognosis (compared to historical expectations). At 6 months and 1 year
Estimate the progression-free survival (PFS). Proportion of subjects alive without progression at 6 months and one year. To demonstrate durability of anti-AML effect. At 6 months and 1 year
Estimate the Duration of response (DOR). Proportion of subjects with response who remain alive and without progression at 6 months and at one year. To demonstrate durability of anti-AML effect. At 6 months and 1 year