Overview

ACHIEVE2 - Safety and Preliminary Efficacy of Intravenous TCB008 in Patients With Relapse or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)/AML

Status:
NOT_YET_RECRUITING

Trial end date:
2027-06-01

Target enrollment:

Participant gender:

Summary

TCB008-003 (ACHIEVE2) is an 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 intravenous doses of TCB008 in patients with Relapse or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)/AML, who have failed or are intolerant to the current standard of care. The dose escalation will follow a 3+3 design with 3 cohorts planned. Once the recommended dose for further investigation has been confirmed, based on dose-limiting toxicities (DLTs), overall safety data, and preliminary efficacy data, up to 20 patients will be enrolled to into one of each of the three dose expansion cohorts.

Phase:

PHASE1

Details

Lead Sponsor:

TC Biopharm

Treatments:

Receptors, Antigen, T-Cell