TC BioPharm (Holdings) PLC, a clinical-stage biotechnology company focused on developing allogeneic gamma-delta T cell therapies for cancer, has announced the FDA's approval of the investigational new drug (IND) application for its Phase 1B study in relapse/refractory Acute Myeloid Leukemia (AML).
The Phase 1B study, named ACHIEVE2, will involve nine patients in a dose-escalating study aimed at assessing safety and optimizing dosage. This open-label, multi-center study, conducted in two parts (dose escalation followed by dose expansion), will evaluate the safety, persistence/expansion, and preliminary efficacy of single and multiple intravenous doses of TCB008 in patients with AML or MDS/AML. Patients may undergo reinfusion with TCB008 up to three times following the initial infusion, as deemed appropriate by the investigator or designee, in accordance with specified protocol criteria.
Additionally, the company plans to continue the UK ACHIEVE trial in AML and expects to submit protocol amendments before the year-end to align dosing and other criteria with the ACHIEVE2 trial of TCBP's lead product.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!