TCB008-001 ACHIEVE trial - TCB008 in AML
Research type
Research Study
Full title
ACHIEVE - An adaptive trial of the 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), myelodysplastic syndrome (MDS) or myeloproliferative neoplasms (MPNs)
IRAS ID
298827
Contact name
Emma Nicholson
Contact email
Eudract number
2021-000744-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
This clinical trial is looking at the safety and effectiveness of the investigational medicinal cell therapy product TCB008 in adult patients with a diagnosis of Acute Myeloid Leukaemia, with either refractory disease (unable to reach a complete response following treatment) or relapsed disease (an initial complete response that cannot be maintained). This will be termed the 'high disease burden' cohort.
As well as this there will be a 'low disease burden' cohort, to include patients with either the pre-secondary AML conditions Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) or low disease burden chemotherapy resistant AML - patients who have achieved a Complete Response following treatment, but who have detectable measurable residual disease (MRD).
This study will follow an adaptive trial approach over two stages, which means that patients will receive one of two doses of the TCB008 product (7 x 10^7 or 7 x 10^8 cells) as an in-patient. Follow-up within the study will be for one year, with consenting patients continuing into a long-term follow-up study. There will be up to 150 patients enrolled in the study.REC name
Scotland B REC
REC reference
22/SS/0006
Date of REC Opinion
2 Mar 2022
REC opinion
Further Information Favourable Opinion