RecruitingPhase 1NCT05680922

DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer

A First in Human Dose Escalation and Cohort Expansion Study of DLL3-directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer


Sponsor

Legend Biotech USA Inc

Enrollment

41 participants

Start Date

Jul 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells in subjects with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy (a type of personalized immune cell treatment) called LB2102, which is designed to find and attack cancer cells that carry a specific marker called DLL3. It is intended for patients with extensive-stage small cell lung cancer or related lung cancers that have come back after prior treatment. **You may be eligible if...** - You are at least 18 years old - You have confirmed extensive-stage small cell lung cancer (SCLC), large cell neuroendocrine carcinoma, or related lung cancers - Your cancer has progressed after at least one standard treatment - You are in good health overall (ECOG 0–1) with a life expectancy of at least 4 months - Your organ function is adequate **You may NOT be eligible if...** - You have previously received CAR-T or gene therapy - You have previously been treated with DLL3-targeted therapies - You have symptomatic brain metastases or leptomeningeal spread - You have active autoimmune disease requiring immune-suppressing treatment - You have significant heart disease or uncontrolled infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLB2102

DLL3 directed autologous Chimeric Antigen Receptor T-cells


Locations(4)

University of Kentucky - Markey Cancer Center

Lexington, Kentucky, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Moffitt Cancer Center

Tampa, Florida, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05680922


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