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A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
Sponsor: Sanofi
Summary
This is a first-in-human (FIH) Phase 1/Phase 2 study for evaluating SAR445514 in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light chain amyloidosis (RRLCA). The study will comprise 3 parts: A dose escalation phase (Part 1) in RRMM participants (Part 1a) that will evaluate several doses administered to determine 2 doses that will be tested in the dose optimization part. A dose escalation will also be done in RRLCA participants (Part 1b) but started sequentially after the end of the dose escalation in RRMM participants. This dose escalation will evaluate the 2 doses planned to be used in dose optimization in RRMM, to ensure those doses are safe also for RRLCA participants. A dose optimization phase (Part 2) that will be evaluating 2 doses determined from Part 1 to determine the preliminary recommended Phase 2 dose (pRP2D) and schedule for SAR445514 in RRMM. A dose expansion phase (Part 3) that will evaluate the preliminary efficacy of pRP2D and schedule for SAR445514 in RRMM (Part 3a) and RRLCA (Part 3b). Approximately 111 participants will be enrolled and treated by study intervention and separated as such: Part 1a: Approximately 30 to 40 participants Part 1b: Approximately 6 to 12 participants Part 2: Approximately 30 participants Part 3a: Approximately 15 participants Part 3b: Approximately 14 participants
Official title: First-in-human, Open-label Phase 1/2 Study to Investigate Safety and Efficacy of SAR445514, an NKcell 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 (RRLCA)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2023-05-15
Completion Date
2025-05-26
Last Updated
2026-05-27
Healthy Volunteers
No
Interventions
SAR445514
Powder for solution for injection. Sub Cutaneous administration.
Locations (16)
Investigational Site Number : 0360001
Wollongong, New South Wales, Australia
Investigational Site Number : 0360002
Richmond, Victoria, Australia
Institut Jules Bordet_Site Number : 0560002
Anderlecht, Belgium
Het Ziekenhuisnetwerk Antwerpen vzw - ZNA Middelheim_Site Number : 0560001-2
Antwerp, Belgium
Het Ziekenhuisnetwerk Antwerpen vzw - ZNA Cadix_Site Number : 0560001-1
Antwerp, Belgium
Investigational Site Number : 0560001
Antwerp, Belgium
Investigational Site Number : 2030002
Brno, Czechia
Investigational Site Number : 2030001
Ostrava, Czechia
Investigational Site Number : 3480001
Budapest, Hungary
Investigational Site Number : 3800001
Rozzano, Lombardy, Italy
Hospital Universitario Marqués de Valdecilla_Site Number : 7240001
Santander, Cantabria, Spain
Institut Catala d´oncologia - Badalona_Site Number : 7240002
Badalona, Catalonia, Spain
HOSPITAL CLINIC i PROVINCIAL BARCELONA_Site Number : 7240003
Barcelona, Spain
Investigational Site Number : 8260003
Birmingham, United Kingdom
Investigational Site Number : 8260002
London, United Kingdom
Investigational Site Number : 8260001
Manchester, United Kingdom