Patients with AML who have completed the induction phase of treatment and have failed to attain a morphological CR will be considered refractory. Patients who have relapsed after previously achieving a morphological CR will also be included. Similarly, patients who have achieved a morphological CR but have detectable measurable residual disease (MRD) by any method will be included, representing low disease burden chemotherapy resistant AML. These patients will be screened according to inclusion and exclusion criteria at the screening visit and enrolled into one of two cohorts: High disease burden cohort (A): relapsed or refractory AML, or Low disease burden cohort (B): MRD persistent AML.~All patients will receive lymphodepleting chemotherapy prior to dosing of TCB008 as an in-patient. Patients will be followed up for up to 52 weeks. Patients may also receive additional dosing based on response assessment.
This is an open label, adaptive, efficacy and effectiveness, phase II clinical trial in adult patients with AML with refractory and relapsed disease. An adaptive trial approach with a two-stage Simon design will be utilised for a total of up to 74 adult patients per dose level of TCB008 cells