|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05891197|
Recruitment Status : **RECRUITING NOW**
First Posted : June 6, 2023
Last Update Posted : June 6, 2023
Information provided by (Responsible Party):
Lyell Immunopharma, Inc.
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.
|Triple Negative Breast Cancer Nonsmall Cell Lung Cancer|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||250 participants|
|Target Follow-Up Duration:||5 Years|
|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|
|Estimated Primary Completion Date :||June 2028|
|Estimated Study Completion Date :||June 2028|
- To identify participants whose tumors express biomarkers, such as ROR1, that may inform eligibility for active and future Lyell clinical trials [ Time Frame: 5 years ]
- To explore tumor expression of biomarkers, such as ROR1, by different methods (e.g., IHC versus next-generation sequencing [NGS]) [ Time Frame: 5 years ]
Biospecimen Retention: Samples Without DNA
An Archival 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Adults 18 years of age or older with histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumor malignancy who are willing to have archival tumor tissue analyzed for biomarker(s).
- Participants aged ≥ 18 years at time of informed consent
- Able to provide informed consent
- 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.
- 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
- Prior solid organ transplantation
- Prior treatment with any adoptive cell therapy
- 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
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): NCT05891197
|Accellacare of Rocky Mount -Dr. Bondy|
|Rocky Mount, North Carolina, United States, 27801|
|Contact: Megan Dixon Meghan.Dixon@accellacare.com|
|Principal Investigator: Paul Bondy, MD|
Lyell Immunopharma, Inc.
|Responsible Party:||Lyell Immunopharma, Inc.|
|Other Study ID Numbers:||LYLSCR-101|
|First Posted:||June 6, 2023 Key Record Dates|
|Last Update Posted:||June 6, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|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.:
Additional relevant MeSH terms:
|Triple Negative Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Neoplasms
Respiratory Tract Diseases
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.