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NCT03967223 (Letetresgene autoleucel in advanced synovial sarcoma or myxoid/round cell…): BVCT ex-ante prediction vs. reported outcome

On 9 Sep 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial failure for this trial. The 13 Nov 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (2L) and commercially TBD (2L OS not mature).

Clinical Trial

NCTID
NCT03967223
Acronym
IGNYTE-ESO
Drug Name
Letetresgene autoleucel (lete-cel; GSK3377794)
Drug MoA
anti-NY-ESO-1 TCR T-cell therapy
Drug Modality
cell therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
advanced synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS)
Human Patients
103
Sponsor
Adaptimmune Therapeutics
Phase
Phase 2

Prediction of , index 1779

Prospective Prediction
Prediction Index
1779
Prediction Date
Commercial Prediction
partial FAILURE (commercially insufficient additive clinical benefit in OS as 1L treatment) partial SUCCESS (commercially maybe sufficient yet weak additive clinical benefit in OS as 2L treatment)
Technical Prediction
partial SUCCESS (statistically maybe significant yet moderate additive clinical benefit in ORR/PFS as 1L treatment with moderate toxicity) SUCCESS (statistically significant additive clinical benefit in ORR/PFS as 2L treatment with moderate toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
65 days in advance
Readout Data Interpretation
lete-cel + SoC as 2L treatment achieved 42% ORR and 5.3 months PFS which is superior to the SoC alone (1L data not reported)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (2L) and commercially TBD (2L OS not mature)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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)
Phase
Phase 2
Status
Active not recruiting
Enrollment
103
Lead sponsor
USWM CT, LLC
Conditions
Neoplasms
Interventions
DRUG: Letetresgene autoleucel (lete-cel, GSK3377794); DRUG: Fludarabine; DRUG: Cyclophosphamide
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2019-12-31
Primary completion
2024-03-01
Completion
2028-07-31
Primary outcomes
  • Substudy 1: Overall response rate (ORR) (Until disease progression (up to 5 years))
  • Substudy 2: Overall response rate (ORR) as assessed by central independent review (Up to 5 years)

NCT03967223 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials