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NCT05712278TERMINATEDanonymous

A Phase I, Single-arm, Open Label, Dose Escalation, Multicenter Study of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)

Sponsor

Source record

Sanofi

Phase

Source record

Phase 1

Modality

AI-normalized

small molecule

Target

AI-normalized

Natural Killer (NK) cells, specifically off-the-shelf allogeneic NK cell product SAR445419.

Indication / condition

AI-normalized

Acute Myeloid Leukaemia

Intervention

Source record

SAR445419, fludarabine, cytarabine

Source & freshness

Source record

NCT ID

NCT05712278

Original source

ClinicalTrials.gov

Source last updated

Jun 05, 2026

Ingested at

Jun 13, 2026

Internal sync

Jun 13, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT05712278

Title

A Phase I, Single-arm, Open Label, Dose Escalation, Multicenter Study of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)

Sponsor

Sanofi

Status

TERMINATED

Phase

Phase 1

Condition raw

Acute Myeloid Leukaemia

Condition normalized

Acute Myeloid Leukaemia

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Natural Killer (NK) cells, specifically off-the-shelf allogeneic NK cell product SAR445419.

Target normalized

Natural Killer (NK) cells, specifically off-the-shelf allogeneic NK cell product SAR445419.

Interventions

SAR445419, fludarabine, cytarabine

Public preview

Source record

SAR445419 is positioned in the competitive landscape of therapies for relapsed or refractory acute myeloid leukemia (R/R AML), a market characterized by high unmet need and limited treatment options. The study's focus on off-the-shelf NK cells may provide a significant advantage in terms of accessibility and scalability compared to autologous therapies. However, the trial has been terminated due to the sponsor's decision, which raises concerns about the viability of the asset and its future in the market. Stakeholders should consider the implications of this termination on Sanofi's pipeline and potential market share in the R/R AML segment, as well as the overall landscape of immunotherapies in hematologic malignancies.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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