NCT05274451

A Study to Investigate LYL797 in Adults With Solid Tumors

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Lyell Immunopharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer (Ovarian cancer), or Endometrial cancer. The first part of the study will determine the safe dose for the next part of the study, and will enroll patients with TNBC, NSCLC, Ovarian or Endometrial cancer. The second part of the study will test that dose in additional patients with TNBC, NSCLC, Ovarian or Endometrial cancer.

Detailed description

This Phase 1, single-arm, open-label, multi-center, dose-escalation and expansion study will evaluate the safety and tolerability of LYL797, ROR1- targeted CAR T cells, in adults with relapsed and/or refractory ROR1+ triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), Ovarian cancer, or endometrial cancer. The dose-escalation phase includes patients with TNBC, NSCLC, Ovarian, or Endometrial cancer, and will investigate multiple dose levels to identify the recommended Phase 2 dose (RP2D). The dose-expansion phase will enroll patients with TNBC, NSCLC, Ovarian, or Endometrial cancer at the RP2D.

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

Type	Name	Description
BIOLOGICAL	LYL797	LYL797 is an autologous, genetically (Gen-R™) and epigenetically (Epi-R™) reprogrammed ROR1-targeted chimeric antigen receptor (CAR) T-cell therapy

Timeline

• Start date: 2022-03-29
• Primary completion: 2024-11-27
• Completion: 2024-11-27
• First posted: 2022-03-10
• Last updated: 2025-07-01

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study