MCARTY
Research type
Research Study
Full title
An open label, Phase 1 study evaluating the activity of Modular CAR T for myeloma
IRAS ID
289627
Contact name
Lydia Lee
Contact email
Sponsor organisation
University College London
Eudract number
2020-005161-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
13 years, 6 months, 30 days
Research summary
Multiple myeloma (MM) is a common blood cancer and despite advances, remains incurable. Thus new treatments are sorely needed. Chimeric Antigen Receptors (also called CAR T cells or CARs) are a treatment where a patient’s own immune cells are modified in the laboratory to target a tumour and then returned by drip. CARs have been effective in leukaemia where they continue to live in patients and suppress cancer for years. In contrast, CAR T cells targeting the myeloma protein BCMA can successfully treat 90% of myeloma patients but the CARs last for a few months and patients relapse after a year.
MCARTY combines two types of CAR T cells. A CAR targeting CD19 which has been shown to be particularly long lasting in patients with leukaemia (CAT) will be combined with a BCMACAR (D8) that in the laboratory, has been shown to work better than a number of BCMACARs that are known to work well in patients. CD19 is a protein expressed on some myeloma cells, especially an aggressive subtype of tumour cell (the ‘myeloma stem’ cells). This trial aims to assess a treatment with increased capacity to kill tumour but that also lasts.
We will modify patient’s T cells in the laboratory to express BCMA CAR (D8) alone or with a CD19 CAR (CAT). Patients will first have chemotherapy with fludarabine and cyclophosphamide to help the CAR T cells grow inside the patient. The first group of patients will receive D8 CAR alone; the second group: D8/CAT CAR. Further cohort(s) may be added via a substantial amendment to either expand Cohorts 1 and 2 or to add an extra engineering module. This trial will be open to patients who have already exhausted multiple lines of therapy. MCARTY aims to assess the safety and effectiveness of this new therapeutic strategy.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/LO/0673
Date of REC Opinion
29 Oct 2021
REC opinion
Further Information Favourable Opinion