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NCT05274451 (LYL797 in Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 18 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 26 Jun 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05274451
Drug Name
LYL797
Drug MoA
Epi-R-enhanced c-JUN-overexpressing anti-ROR1 CAR-T therapy
Drug Modality
CAR-T therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Solid Tumors
Human Patients
54
Sponsor
Lyell Immunopharma
Phase
Phase 1

Prediction of , index 1478

Prospective Prediction
Prediction Index
1478
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit superior to other CAR-T therapies for ROR1+ advanced solid tumors)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS/OS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
129 days in advance
Readout Data Interpretation
40% ORR (superior to 27% placebo-adjusted ORR by trodelvy for advanced TNBC in ASCENT study) yet with 35% grade>3 TEAEs (pneumonitis and hypoxia).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies
Phase
Phase 1
Status
Terminated
Enrollment
57
Lead sponsor
Lyell Immunopharma, Inc.
Conditions
Triple Negative Breast Cancer; TNBC - Triple-Negative Breast Cancer; Non-small Cell Lung Cancer; Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Metastatic; Non-Small Cell Carcinoma of Lung, TNM Stage 4; Advanced Breast Cancer; Advanced Lung Carcinoma; NSCLC; NSCLC, Recurrent; NSCLC Stage IV; Relapsed Cancer; Relapse/Recurrence; Recurrent Breast Cancer; Recurrent NSCLC; Platinum-resistant Ovarian Cancer; Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Endometrial Cancer; Endometrioid Tumor; High Grade Serous Carcinoma; Ovarian Epithelial Cancer
Interventions
BIOLOGICAL: LYL797
Design
Single group · None
Primary purpose
Treatment
Start
2022-03-29
Primary completion
2024-11-27
Completion
2024-11-27
Primary outcomes
  • Evaluate incidence of dose-limiting toxicities (DLTs) (Up to 28 days)
  • Evaluate incidence of treatment-emergent adverse events (TEAEs) (Up to 2 years)
  • Evaluate severity of treatment-emergent adverse events (TEAEs) (Up to 2 years)
  • Determine recommended Phase 2 Dose (RP2D) (Up to 2 years)

NCT05274451 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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