OnCo
drugsProductPhase 2

Letetresgene autoleucel

Letetresgene autoleucel is a second engineered T-cell receptor therapy for sarcoma, targeting NY-ESO-1 in synovial sarcoma and myxoid/round cell liposarcoma; a BLA is expected by the end of 2026.

IGNYTE-ESO: ORR 42% (27/64) by independent review; 41% synovial sarcoma, 43% MRCLS; median DOR 12.2 months (18.3 in synovial). Breakthrough Therapy designation for MRCLS. Rights passed from GSK to Adaptimmune (2023) to US WorldMeds (August 2025), which committed to a BLA by 31 December 2026.

Schematic of the modality · TCR-T (NY-ESO-1) · not a molecule; see the TCR-T cell therapy page
How it works, step by step · animated schematic, not to scale
TCR-T cell therapy
Modality
TCR-T (NY-ESO-1)
Mechanism
Autologous T cells with an affinity-enhanced TCR against NY-ESO-1/LAGE-1a peptide on HLA-A*02; lymphodepletion then infusion.
Brand / code
lete-cel, GSK3377794

Regulatory

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  1. Jun 2024DesignationUS

    Breakthrough Therapy for MRCLS

  2. 4 Aug 2025Filing / dealUS

    Asset transferred to US WorldMeds; BLA committed by end-2026

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
5 studies0 recruiting5 Phase 2
Search “Letetresgene autoleucel” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Letetresgene autoleucel
intervention: Letetresgene autoleucel
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Key papers

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Latest papers

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Literature trend3 papers in the last 12 months-57% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Letetresgene autoleucel" OR ABSTRACT:"Letetresgene autoleucel" OR TITLE:"lete-cel" OR ABSTRACT:"lete-cel" OR TITLE:"GSK3377794" OR ABSTRACT:"GSK3377794") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Letetresgene autoleucel, not a curated reading list.

Connected

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