LAUREL
Research type
Research Study
Full title
A PHASE I OPEN-LABEL DOSE ESCALATION STUDY OF INTRAVENOUS INKMUNE IN PATIENTS WITH MYELODYSPLASTIC SYNDROME WITH EXCESS BLASTS (MDS-EB-1/2 - MDS-CMML 1/2) OR ACUTE MYELOID LEUKAEMIA
IRAS ID
277258
Contact name
Kim Orchard
Contact email
Sponsor organisation
INmune Bio International Ltd
Eudract number
2019-004820-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
Myelodysplastic Syndrome (MDS) is a disorder in which the bone marrow fails to produce healthy blood cells despite normal circulating levels. This can affect all blood cells (white blood cells, red blood cells and platelets) causing a range of symptoms with risk of progression to acute myeloid leukaemia (AML) with a rapidly fatal outcome. At present there are only three drugs approved and no agent approved for second-line therapy. This means there is a significant unmet need for management of MDS within all risk groups. As a result of this, we are proposing a potential new therapy, INKmune. We believe INKmune will activate or switch on circulating natural killer cells in patients and will help kill residual MDS cells left after their previous chemotherapy and therefore reduce the risk of the disease getting worse. Our main objective is to evaluate the safety and tolerability of INKmune and to determine a suitable dose for phase 2.
This will be a single centre; first in human, dose escalation, open label study. We aim to recruit 9-12 MDS patients who will each receive 3 doses of INKmune cell infusions on Days 1,8, 15. Subjects will be in the study for 4 months with 8 scheduled visits, this includes screening, dosing visits and follow up visits.
The study is split into three cohorts. We aim to give the following doses intravenously:
Cohort 1: 3 doses of INKmune at 1 x 10^8 cells.
Cohort 2: 3 doses of INKmune at 5 x 10^8 cells.
Cohort 3: 3 doses of INKmune at 1 x 10^9 cells.REC name
Scotland B REC
REC reference
20/SS/0043
Date of REC Opinion
15 Jun 2020
REC opinion
Further Information Favourable Opinion