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A Study to Investigate LYL797 in Adults With Solid Tumors

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial 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) or non-small cell lung cancer (NSCLC). The first part of the study will determine the safe dose for the next part of the study, and will enroll TNBC and NSCLC patients. The second part of the study will test that dose in additional TNBC and NSCLC patients.

Clinical Trial Description

This Phase 1, single-arm, open-label, multi-center, dose-escalation and -expansion study will evaluate the safety and tolerability of LYL797, ROR1-targeting CAR T cells, in adults with relapsed and/or refractory ROR1+ triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC). The dose-escalation phase includes TNBC and NSCLC patients, and will investigate 4 dose levels to determine the recommended Phase 2 dose (RP2D). The dose-expansion phase will enroll both TNBC and NSCLC patients at the RP2D. ;

Study Design

Related Conditions & MeSH terms

  • Advanced Breast Cancer
  • Advanced Lung Carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer Metastatic
  • Non-Small Cell Carcinoma of Lung, TNM Stage 4
  • Non-small Cell Lung Cancer
  • NSCLC
  • NSCLC Stage IV
  • NSCLC, Recurrent
  • Recurrence
  • Recurrent Breast Cancer
  • Recurrent NSCLC
  • Relapse/Recurrence
  • Relapsed Cancer
  • TNBC - Triple-Negative Breast Cancer
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
Clinical Trial Details
NCT number NCT05274451
Study type Interventional
Source Lyell Immunopharma, Inc.
Contact Jackie Walling, MD, PhD
Phone 888-707-7917
Email clinicaltrials@lyell.com
Status Recruiting
Phase Phase 1
Start date March 29, 2022
Completion date September 2026
View Details
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