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NCT03602157 · ClinicalTrials.gov registry record · Phase 1
Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL
A Phase 1 study of Lymphoma and Neoplasms, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT03602157 is a Phase 1 study of Lymphoma and Neoplasms that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 43 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03602157, a Phase 1 study of Lymphoma and Neoplasms, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
The body has different ways of fighting infection and disease. No single way is perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances. Antibodies work by binding bacteria or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with bacteria or viruses. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been sufficient to treat cancer. This study will combine both T cells and antibodies in order to create a more effective treatment called Autologous T Lymphocyte Chimeric Antigen Receptor cells targeted against the CD30 antigen (ATLCAR.CD30). Another treatment being tested includes the Autologous T Lymphocyte Chimeric Antigen Receptor cells targeted against the CD30 antigen with CCR4 (ATLCAR.CD30.CCR4) to help the cells move to regions in the patient's body where the cancer is present. Participants in this study will receive either ATLCAR.CD30.CCR4 cells alone or will receive ATLCAR.CD30.CCR4 cells combined with ATLCAR.CD30 cells. Previous studies have shown that a new gene can be put into T cells that will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes an antibody called anti-CD30. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been used to treat people with lymphoma but have not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Bendamustine
- BIOLOGICAL ATLCAR.CD30.CCR4 cells
- BIOLOGICAL ALTCAR.CD30 cells
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2039-11-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03602157
The ClinicalTrials.gov registry entry for NCT03602157 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (91% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Fludarabine is the first listed.
NCT03602157 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT03602157 about?
NCT03602157 is a clinical study titled "Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL". The body has different ways of fighting infection and disease. No single way is perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances....
What is the current status of trial NCT03602157?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2018-12-12. Estimated completion is 2039-11-04.
What conditions does trial NCT03602157 study?
This clinical trial studies the following conditions: Lymphoma, Neoplasms, Mycosis Fungoides, Immune System Diseases, Sezary Syndrome.
What interventions are being tested in trial NCT03602157?
The interventions under investigation include: Fludarabine (DRUG), Bendamustine (DRUG), ATLCAR.CD30.CCR4 cells (BIOLOGICAL), ALTCAR.CD30 cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03602157?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03602157 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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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.