Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513032-14-00

Acronym

208467

Enrollment

Registered

2024-06-17

Start date

2020-04-21

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Synovial sarcoma and Myxoid/Round Cell Liposarcoma (MRCLS)

Brief summary

Overall Response Rate (ORR) per RECIST v1.1

Detailed description

To evaluate efficacy of NY-ESO -1 ∙ Time to Response (TTR) ∙ Duration of Response (DoR) ∙ Disease Control Rate (DCR) ∙ Progression Free Survival (PFS), To evaluate safety and tolerability of NY-ESO-1 ∙ Frequency and severity of Adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI; as defined in protocol) ∙ Laboratory parameters ∙ Replication Competent Lentivirus (RCL) ∙ Instances of Insertional oncogenesis (IO)

Interventions

DRUGGSK3377794

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Response Rate (ORR) per RECIST v1.1	—

Secondary

Measure	Time frame
To evaluate efficacy of NY-ESO -1 ∙ Time to Response (TTR) ∙ Duration of Response (DoR) ∙ Disease Control Rate (DCR) ∙ Progression Free Survival (PFS), To evaluate safety and tolerability of NY-ESO-1 ∙ Frequency and severity of Adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI; as defined in protocol) ∙ Laboratory parameters ∙ Replication Competent Lentivirus (RCL) ∙ Instances of Insertional oncogenesis (IO)	—

Measure

Time frame

—

Countries

France, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026