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Lyell START: A Biomarker Screening Protocol to Support Preliminary Eligibility for Clinical Trials Evaluating Safety and Efficacy of Adoptive T-cell Therapies in Participants With Solid Tumors

Sponsor
Lyell Immunopharma, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05891197
Collaborator
ICON plc (Industry)
250
Enrollment
1
Location
60.5
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Biomarker Screening Protocol for Preliminary Eligibility Determination for Adoptive T-cell Therapy Trials:This is a decentralized, multi-site, US-based biomarker screening study to identify participants who have specific disease indications and tumor expression of target(s) of interest that may inform eligibility for active and future Lyell clinical trials. No investigational treatments will be administered in this non-interventional screening study. Only previously obtained archival tumor tissue will be allowed on this study for biomarker analysis. Fresh tumor biopsies are not permitted on this study. The study will be conducted virtually and participants will utilize telehealth and e-consent modules. If participants tumors express the biomarkers of interest they can be referred to open and enrolling clinical trials. Participation on the screening study does not guarantee enrollment or treatment on an interventional clinical trial.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    A Biomarker Screening Protocol to Support Preliminary Eligibility for Clinical Trials Evaluating Safety and Efficacy of Adoptive T-cell Therapies in Participants With Solid Tumors
    Actual Study Start Date :
    May 19, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2028
    Anticipated Study Completion Date :
    Jun 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. To identify participants whose tumors express biomarkers, such as ROR1, that may inform eligibility for active and future Lyell clinical trials [5 years]

    Secondary Outcome Measures

    1. To explore tumor expression of biomarkers, such as ROR1, by different methods (e.g., IHC versus next-generation sequencing [NGS]) [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Participants aged ≥ 18 years at time of informed consent

    2. Able to provide informed consent

    3. Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumor malignancy.The Sponsor will indicate which solid tumor disease indications are open to enrollment.

    4. Ability to provide a tumor tissue sample collected within 3 years prior to enrollment. The sample must consist, at minimum, of 5 freshly cut, unstained 4-5 μM sections cut from a formalin-fixed paraffin-embedded (FFPE) tissue block. The sample must contain sufficient tumor tissue to allow for the evaluation of biomarker expression

    Exclusion Criteria:

    1. Prior solid organ transplantation

    2. Prior treatment with any adoptive cell therapy

    3. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with a clinical study, as judged by the Investigator or Sponsor's Medical Monitor

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Accellacare of Rocky Mount -Dr. Bondy Rocky Mount North Carolina United States 27801

    Sponsors and Collaborators

    • Lyell Immunopharma, Inc.
    • ICON plc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lyell Immunopharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT05891197
    Other Study ID Numbers:
    • LYLSCR-101
    First Posted:
    Jun 6, 2023
    Last Update Posted:
    Jun 6, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lyell Immunopharma, Inc.
    Biomarker Screening
    Immunotherapy
    CAR-T
    ROR1
    Additional relevant MeSH terms:
    Triple Negative Breast Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jun 6, 2023