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Trial record 1 of 1 for:    nct05274451
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A Study to Investigate LYL797 in Adults With Solid Tumors

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ClinicalTrials.gov Identifier: NCT05274451
Recruitment Status : Recruiting
First Posted : March 10, 2022
Last Update Posted : August 1, 2022
Information provided by (Responsible Party):
Lyell Immunopharma, Inc.

Brief 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 patients only. The second part of the study will test that dose in additional TNBC patients and NSCLC patients.

Condition or disease Intervention/treatment Phase
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 Biological: LYL797 Phase 1

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-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 (TNBC only), and will investigate 4 dose levels to determine the recommended Phase 2 dose (RP2D). The dose-expansion phase will enroll both TNBC and NSCLC at the RP2D.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm, open-label, dose-escalation and -expansion study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 29, 2022
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Evaluate incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 2 years ]
    Incidence of dose-limiting toxicities (DLTs)

  2. Evaluate incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]
    Incidence of treatment-emergent adverse events (TEAEs)

  3. Evaluate severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]
    Severity of treatment-emergent adverse events (TEAEs)

  4. Determine recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 2 years ]
    Dose-escalation phase to determine the recommended Phase 2 dose

Secondary Outcome Measures :
  1. Evaluate anti-tumor activity of LYL797 based on overall response rate (ORR) by RECIST, version 1.1 [ Time Frame: Up to 2 years ]
    Overall response rate (ORR) by RECIST, version 1.1

  2. Evaluate anti-tumor activity of LYL797 based on complete response (CR) rate by RECIST, version 1.1 [ Time Frame: Up to 2 years ]
    Complete response (CR) rate by RECIST, version 1.1

  3. Evaluate duration of response (DOR) [ Time Frame: Up to 2 years ]
    Duration of response (DOR)

  4. Evaluate progression-free survival (PFS) [ Time Frame: Up to 2 years ]
    Progression-free survival (PFS)

  5. Evaluate overall survival (OS) [ Time Frame: Up to 2 years ]
    Overall survival (OS)

  6. Evaluate maximum concentration of LYL797 (Cmax) of LYL797 in peripheral blood (PB) samples [ Time Frame: Up to 2 years ]
    Maximum concentration of LYL797 (Cmax)

  7. Evaluate time to Cmax (Tmax) of LYL797 in peripheral blood (PB) samples [ Time Frame: Up to 2 years ]
    Time to Cmax (Tmax)

  8. Evaluate area under the concentration-time curve (AUC) of LYL797 in the peripheral blood (PB) [ Time Frame: Up to 2 years ]
    Area under the concentration-time curve (AUC)

  9. Evaluate Persistence of LYL797 CAR T cells in peripheral blood samples [ Time Frame: Up to 2 years ]
    Persistence of LYL797 in PB

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05274451

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Contact: Heidi Gillenwater, MD 888-707-7917 clinicaltrials@lyell.com

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United States, Connecticut
Yale New Haven Hospital Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Michael Hurwitz, MD    203-785-4095      
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Hemant Murthy, MD    855-776-0015      
United States, New York
Roswell Park Comprehensive Cancer Center Not yet recruiting
Buffalo, New York, United States, 14203
Contact: Grace Dy, MD    800-767-9355      
United States, Oregon
Oregon Health and Science University Hospital Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Richard Maziarz, MD    503-494-1080    trials@ohsu.edu   
United States, Pennsylvania
Sidney Kimmel Cancer Center, Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Babar Bashir, MD    215-955-1661      
United States, Tennessee
Sarah Cannon Research Institute and Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: David Spigel, MD    844-482-4812      
United States, Wisconsin
Froedtert Hospital, Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lubna Chaudhary, MD    414-805-3666      
Sponsors and Collaborators
Lyell Immunopharma, Inc.
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Study Director: Heidi Gillenwater, MD Lyell Immunopharma, Inc.
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Responsible Party: Lyell Immunopharma, Inc.
ClinicalTrials.gov Identifier: NCT05274451    
Other Study ID Numbers: LYL797-101
First Posted: March 10, 2022    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lyell Immunopharma, Inc.:
CAR T-cell therapy
CAR T-cell
CAR-T cell therapy
CAR-T cell
ROR1 positive
cell therapy
solid tumor
breast cancer
lung cancer
triple negative breast cancer
non small cell lung cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms