TCD17710
Research type
Research Study
Full title
First-in-human, open-label Phase 1/2 study to investigate safety and efficacy of SAR445514, an NK-cell engager (NKCE) targeting B-cell maturation antigen (BCMA) in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and in relapsed/refractory light-chain amyloidosis (RR LCA).
IRAS ID
1007232
Contact name
Lukasz Wardzinski
Contact email
Sponsor organisation
Sanofi-aventis recherche & développement
Eudract number
2022-502057-33
Clinicaltrials.gov Identifier
Research summary
The sponsor is developing a new medicine (SAR445514) in people with either Multiple Myeloma or Light Chain Amyloidosis. Myeloma is a type of cancer that develops from cells in the bone marrow. Amyloidosis is a rare condition also affecting the bone marrow, with cells making abnormal protein (amyloid) that can build up in organs like heart or kidney and cause failure of such organs. Amyloidosis isn’t a cancer but is sometimes associated with myeloma and treated with the same treatment.
This is a first-in-human study and only patients whose disease has progressed on available treatment are eligible. The purpose of this study is to find a safe dose, side-effects and if the treatment can control or improve the disease.
The trial is looking to recruit patients, ≥18 years, across three NHS hospitals, all specialist cancer centres.
The medicine will be given by injection under the skin in 4-week ‘cycles’. In cycle 1 it will be given every week, in cycle 2-12 every 2 weeks, and after that every 4 weeks.
Before the start, patients will have a PET-CT scan, echocardiogram of the heart, and bone marrow samples. These are routine tests for this patient group. During the study, for safety and to know if and how the medicine is working, participants will give blood and urine samples and ECG recording of the heart. For those whose disease has spread to their bones, the PET-CT is repeated every 12-weeks until they stop the medicine, or to confirm response of disease to the medicine or for other clinical reasons as needed.
Patients will be able to receive the medicine until it stops working for them or if they, or their study doctor, decides they should stop taking it. They will be followed up for 90 days after the last dose is given.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0030
Date of REC Opinion
4 May 2023
REC opinion
Further Information Favourable Opinion