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NCT05620342 · ClinicalTrials.gov registry record · Early Phase 1
Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer
A Early Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05620342 is a Early Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 24 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05620342, a Early Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase 1, single-center, open-label study that enrolls adult subjects with extensive stage lung cancer or stage IV non-small cell lung cancer that is platinum-refractory and received PD-1 and/or PD-L1 therapy. The purpose of this study is to test the safety of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the GD2 antigen (iC9-GD2.CAR.IL-15 T cells) in subjects with lung cancer. How much (dose) of the iC9-GD2.CAR.IL-15 T cells are safe to use without causing too many side effects and what is the maximum dose that could be tolerated will be studied. Modified immune cells as an experimental treatment that combines antibodies and T cells will be used. Antibodies are proteins that protect the body from foreign invaders like bacteria. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill viruses and other cells, including tumor cells. Although antibodies and T cells have been used to treat cancer and they both have shown promise, neither alone has been able to cure most patients. This study will combine T cells and antibodies to create a more effective treatment. The treatment that is being researched in this study is called autologous T lymphocyte chimeric antigen receptor cells targeted against the disialoganglioside (GD2) antigen that expresses Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9). The short name for this treatment is iC9.GD2.CAR.IL-15 T cells therapy is an experimental therapy and has not been approved by the Food and Drug Administration. There are two steps. In the first step, blood will be collected from the subjects to prepare the iC9-GD2.CAR.IL-15 T cells. T cells will be isolated from the blood and modified to make iC9-GD2.CAR.IL-15. In the second step, the iC9-GD2.CAR.IL-15 T cells produced from the subject's own blood will be administered to the subject.
Conditions Studied
Interventions
- BIOLOGICAL iC9.GD2.CAR.IL-15 T Infusion
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-06-21 |
| Est. Completion | 2029-10-24 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05620342
The ClinicalTrials.gov registry entry for NCT05620342 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which iC9.GD2.CAR.IL-15 T Infusion is the first listed.
NCT05620342 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05620342 about?
NCT05620342 is a clinical study titled "Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer". This is a phase 1, single-center, open-label study that enrolls adult subjects with extensive stage lung cancer or stage IV non-small cell lung cancer that is platinum-refractory and received PD-1 and/or PD-L1 therapy. The purpose of this study is to test the safety of using a new treatment called a...
What is the current status of trial NCT05620342?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2023-06-21. Estimated completion is 2029-10-24.
What conditions does trial NCT05620342 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Lung Cancer, Small Cell Lung Carcinoma.
What interventions are being tested in trial NCT05620342?
The interventions under investigation include: iC9.GD2.CAR.IL-15 T Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT05620342?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05620342 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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