Safety, tolerability, anti-tumour activity, and PK of REGN5458
Research type
Research Study
Full title
PHASE 1/2 FIH STUDY OF REGN5458 (ANTI-BCMA X ANTI-CD3 BISPECIFIC ANTIBODY) IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA
IRAS ID
304800
Contact name
Martin Kaiser
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2018-003188-78
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 138791
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Multiple myeloma (MM) is a malignancy associated with the clonal proliferation of plasma cells.
Multiple myeloma comprises approximately 13% of haematologic cancers and is the second most common haematological malignancy after non-Hodgkin lymphoma.
Multiple myeloma commonly presents with organ impairment such as renal dysfunction (due to filtered free light chains leading to cast nephropathy or amyloidosis, among other mechanisms), bone infiltration by malignant plasma cells, hypercalcemia, and haematopoietic suppression due to bone marrow infiltration.REGN5458 is an anti-BCMA x anti-CD3 bispecific antibody that binds to BCMA on MM (Multiple myeloma) cells and to CD3 on T-cells. In vitro, REGN5458 triggers activation of Jurkat T-lymphocytes only in the presence of human BCMA-expressing cells. REGN5458 can mediate the killing of numerous MM cell lines and primary MM cells with a range of BCMA cell surface expression. REGN5458 may provide therapeutic benefit to patients with MM.
This is a phase 1/2, open-label, FIH study of the safety, tolerability, anti-tumour activity, and PK (pharmacokinetic) of REGN5458 (anti-BCMA x anti-CD3 bispecific antibody) in patients with relapsed or refractory MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit.
REC name
Wales REC 1
REC reference
22/WA/0029
Date of REC Opinion
4 Feb 2022
REC opinion
Favourable Opinion