TC BioPharm: FDA OKs Phase 1B IND for TCB-008 in Acute Myeloid Leukemia

  TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, announced today that the FDA  provides clearance on the Company's investigational new drug (IND) application for a Phase 1B study in relapse/refractory Acute Myeloid Leukemia (AML).

The Phase 1B study, dubbed ACHIEVE2, will be a 9 patient, dose escalating study measuring for safety and dose optimization. The Open-label, multi-center study conducted in 2 parts (dose escalation followed by dose expansion) will evaluate safety, persistence/expansion, and preliminary efficacy of single and multiple IV doses of TCB008 in patients with AML or MDS/AML. Patients may be reinfused with TCB008 up to 3 times following initial infusion as deemed appropriate by the investigator or designee should protocol specified criteria be met.

https://www.biospace.com/article/releases/tc-biopharm-announces-fda-clearance-of-phase-1b-ind-for-tcb-008-in-acute-myeloid-leukemia/