Investor Presentaiton
ACHIEVE2 (TCB008-003) Ph I US Study (In Planning)
TC
BIOPHARM
Open-label, multi-center study conducted in 2 parts (dose escalation followed by dose expansion) to evaluate safety, persistence/expansion, and
preliminary efficacy of single and multiple IV doses of TCB008 in patients with AML or MDS/AML, MRD-persistent AML, or MDS/AML who have failed
or are intolerant to the current standard of care.
Proposed Primary Objectives:
•
To establish the recommended dose for further investigation in the dose-expansion part of the study, in patients with previously treated relapsed
or relapsed refractory AML or MDS/AML, or MRD persistent-AML or MDS/AML (dose escalation part only)
To determine the safety and tolerability of TCB008 in patients with previously treated relapsed or relapsed refractory AML or MDS/AML, or MRD-
persistent AML or MDS/AML
Proposed Number of Patients:
•
•
Dose escalation: approximately 9 to 24 DLT evaluable patients are planned to follow a 3 + 3 enrollment design. Non-DLT-evaluable patients will be
replaced.
Dose expansion: Up to 60 patients are planned (up to 20 patients in each of the 3 cohorts)
Proposed Dosing Regime:
•
Dose escalation:
•
Cohort 1: 1.5 mL TCB008 (3.6×107 to 6.9×107 cells)
•
Cohort 2: up to 5 mL TCB008 (12.0×107 to 23.0×107 cells)
•
Cohort 3: up to 18 mL TCB008 (43.2×107 to 82.8×107 cells)
The dose level for the dose expansion will be based on the recommended dose for further investigation (RDE) determined in the dose escalation
part of the study
Patients may be reinfused with TCB008 up to 3 times following initial infusion (at the same dose as the initial infusion) as deemed appropriate by the investigator or designee should protocol
specified criteria be met.
Protocol finalized in October 2023, First Patient Dosed Q2 2024
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