NCT05839626

A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)

Terminated Phase 1, PHASE2 Last updated 12 June 2025

What this trial tests

Phase 1, PHASE2 trial testing SAR445514 in Relapsed/Refractory Multiple Myeloma in 32 participants. Terminated before completion.

Timeline

15 May 2023

Primary endpoint
26 May 2025

26 May 2025

Quick facts

Lead sponsor	Sanofi
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	15 May 2023
Primary completion	26 May 2025
Estimated completion	26 May 2025
Sites	16 locations across Italy, Belgium, United Kingdom, Hungary, Australia, Spain, Czechia

Drugs / interventions tested

• SAR445514 — full drug profile →

Conditions studied

• Relapsed/Refractory Multiple Myeloma — all drugs for Relapsed/Refractory Multiple Myeloma →
• Amyloid Light-chain Amyloidosis — all drugs for Amyloid Light-chain Amyloidosis →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Relapsed/Refractory Multiple Myeloma or Amyloid Light-chain Amyloidosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bi- and trispecific immune cell engagers for immunotherapy of hematological malignancies.
   Tapia-Galisteo A, Álvarez-Vallina L, Sanz L. · · 2023 · cited 87× · PMID 37501154 · DOI 10.1186/s13045-023-01482-w
2. Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
   Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
3. Therapeutic approaches to enhance natural killer cell cytotoxicity.
   Stenger TD, Miller JS. · · 2024 · cited 14× · PMID 38545115 · DOI 10.3389/fimmu.2024.1356666
4. Natural killer cell engagers: From bi-specific to tri-specific and tetra-specific engagers for enhanced cancer immunotherapy.
   Zhu A, Bai Y, Nan Y, Ju D. · · 2024 · cited 13× · PMID 39472273 · DOI 10.1002/ctm2.70046
5. Natural killer cell engagers for cancer immunotherapy.
   Nikkhoi SK, Li G, Hatefi A. · · 2024 · cited 12× · PMID 39911822 · DOI 10.3389/fonc.2024.1483884
6. Natural killer cell biology and therapy in multiple myeloma: challenges and opportunities.
   Bisht K, Merino A, Igarashi R, Gauthier L, et al · · 2024 · cited 8× · PMID 39538354 · DOI 10.1186/s40164-024-00578-4
7. An Updated Comprehensive Review on Diseases Associated with Nephrotic Syndromes.
   Wendt R, Sobhani A, Diefenhardt P, Trappe M, et al · · 2024 · cited 8× · PMID 39457572 · DOI 10.3390/biomedicines12102259
8. Harnessing natural killer cell effector function against cancer.
   Blunt MD, Khakoo SI. · · 2024 · cited 8× · PMID 38223411 · DOI 10.1093/immadv/ltad031