* Isatuximab in adults with warm autoimmune hemolytic anemia
Research type
Research Study
Full title
A multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia
IRAS ID
291265
Contact name
Marie Scully
Contact email
Sponsor organisation
Sanofi-Aventis Recherche et Développement
Eudract number
2020-003880-24
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
151491, IND; U1111-1255-5350, WHO
Duration of Study in the UK
2 years, 4 months, 5 days
Research summary
Warm autoimmune hemolytic anemia (wAIHA) is a disease defined by the aberrant production of autoantibodies directed against red blood cells. The primary antibody-producing cell of the body is the plasma cell, which has a life span of months to years and is hypothesized to be responsible for the persistence of autoantibody production in individuals with refractory wAIHA. Plasma cells express a high density of CD38, and the anti-CD38 monoclonal antibody isatuximab is expected to deplete these antibody-producing cells, which are not targeted by glucocorticoids, antiproliferatives, or B-cell depletion by anti-CD20 therapy.
Isatuximab (or SAR650984) is a type of drug called monoclonal antibody (a type of protein) and is approved for use in patients with multiple myeloma. The purpose of this study is to assess isatuximab in participants with wAIHA who have failed to respond to prior therapy. The first part of this study will assess safety and determine the isatuximab dose for patients with wAIHA, and the second part of the study will assess efficacy.
The study is a non-randomised, single group assignment that will include about 23 patients with wAIHA. About 2 will be from the UK. Isatuximab will be administered via subcutaneous (injection) every 2 weeks. Participants in the first cohort of Part A will receive 2 doses; all other participants will receive 6 doses. The treatment period is 42 days for Cohort 1, or 84 days for the other participants in the trial.
A pharmaceutical company (Sanofi) is sponsoring this study. The study is planned to take part in 1 NHS centre in England and will last approximately 27 months.REC name
London - Dulwich Research Ethics Committee
REC reference
21/FT/0011
Date of REC Opinion
4 Mar 2021
REC opinion
Further Information Favourable Opinion