ACHIEVE - Efficacy and Effectiveness of Adoptive Cellular tHerapy wIth Ex-Vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) for Patients With Refractory or Relapsed Acute Myeloid Leukaemia (AML)

Phase 2 Terminated 16 enrolled TC Biopharm

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with Acute Myeloid Leukemia (AML), or Myelodysplastic Syndromes (MDS)/AML, with either refractory or relapsed disease. Five patients will be recruited for an initial safety cohort. The safety cohort will be followed by a two-stage Simon's Design, where a further 48 patients will be recruited into one of two cohorts and dosed with TCB008.

Timeline

Start: 2022-08-15
Primary completion: 2025-07-30
Completion: 2025-07-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TCB008	Cell therapy	1.8 ml	—
Subject	TCB008	Cell therapy	5 ml	—

ACHIEVE - Efficacy and Effectiveness of Adoptive Cellular tHerapy wIth Ex-Vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) for Patients With Refractory or Relapsed Acute Myeloid Leukaemia (AML)

Summary

Timeline

Drugs

Indications