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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05274451
Other study ID # LYL797-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 29, 2022
Est. completion date September 2026

Study information

Verified date February 2024
Source Lyell Immunopharma, Inc.
Contact Jackie Walling, MD, PhD
Phone 888-707-7917
Email clinicaltrials@lyell.com
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date September 2026
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - = 18 years of age at time of informed consent - Histologically confirmed TNBC or NSCLC that is relapsed or refractory, metastatic or locally advanced and unresectable that is ROR1+ by central laboratory immunohistochemistry (IHC) - Measurable disease including a target lesion and an additional lesion for biopsy - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Adequate organ and marrow function - Women of childbearing potential must have a negative pregnancy test at screening - All participants must agree to practice highly effective methods of contraception Exclusion Criteria: - Prior treatment with any adoptive T-cell therapy or anti-ROR1 therapy - Prior solid organ transplantation - Active, untreated brain metastasis or leptomeningeal disease; stable, treated brain involvement by disease is allowed - Untreated or active infection at the time of screening or leukapheresis - HIV-positive, HTLV-1-positive, active acute or chronic HBV or HCV, or active tuberculosis - Impaired cardiac function or clinically significant cardiac disease - Uncontrolled pleural or pericardial effusion - Systemic corticosteroids or other immunosuppressive medications within 14 days of leukapheresis - Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or Factor Xa inhibitors - Pregnant or lactating/nursing women

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

Intervention

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

Locations

Country Name City State
United States Montefiore Medical Center Bronx New York
United States University of Chicago Chicago Illinois
United States Karmanos Cancer Institute Detroit Michigan
United States MD Anderson Cancer Center Houston Texas
United States Mayo Clinic Jacksonville Florida
United States University of Miami Miami Florida
United States Froedtert Hospital, Medical College of Wisconsin Milwaukee Wisconsin
United States Sarah Cannon Research Institute and Tennessee Oncology Nashville Tennessee
United States Yale New Haven Hospital New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York
United States University of Oklahoma Oklahoma City Oklahoma
United States Sidney Kimmel Cancer Center, Jefferson University Hospital Philadelphia Pennsylvania
United States Oregon Health and Science University Hospital Portland Oregon
United States Mayo Clinic Rochester Minnesota
United States University of California, Los Angeles Santa Monica California
United States Mayo Clinic Scottsdale Arizona
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Georgetown University Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Lyell Immunopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate incidence of dose-limiting toxicities (DLTs) Incidence of dose-limiting toxicities (DLTs) Up to 2 years
Primary Evaluate incidence of treatment-emergent adverse events (TEAEs) Incidence of treatment-emergent adverse events (TEAEs) Up to 2 years
Primary Evaluate severity of treatment-emergent adverse events (TEAEs) Severity of treatment-emergent adverse events (TEAEs) Up to 2 years
Primary Determine recommended Phase 2 Dose (RP2D) Dose-escalation phase to determine the recommended Phase 2 dose Up to 2 years
Secondary Evaluate anti-tumor activity of LYL797 based on overall response rate (ORR) by RECIST, version 1.1 Overall response rate (ORR) by RECIST, version 1.1 Up to 2 years
Secondary Evaluate anti-tumor activity of LYL797 based on complete response (CR) rate by RECIST, version 1.1 Complete response (CR) rate by RECIST, version 1.1 Up to 2 years
Secondary Evaluate duration of response (DOR) Duration of response (DOR) Up to 2 years
Secondary Evaluate progression-free survival (PFS) Progression-free survival (PFS) Up to 2 years
Secondary Evaluate overall survival (OS) Overall survival (OS) Up to 2 years
Secondary Evaluate maximum concentration of LYL797 (Cmax) of LYL797 in peripheral blood (PB) samples Maximum concentration of LYL797 (Cmax) Up to 2 years
Secondary Evaluate time to Cmax (Tmax) of LYL797 in peripheral blood (PB) samples Time to Cmax (Tmax) Up to 2 years
Secondary Evaluate area under the concentration-time curve (AUC) of LYL797 in the peripheral blood (PB) Area under the concentration-time curve (AUC) Up to 2 years
Secondary Evaluate Persistence of LYL797 CAR T cells in peripheral blood samples Persistence of LYL797 in PB Up to 2 years
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