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NCT03672318 · ClinicalTrials.gov registry record · Phase 1
Study of ATLCAR.CD138 Cells for Relapsed/Refractory Multiple Myeloma
A Phase 1 study of Multiple Myeloma and Immune System Diseases, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT03672318 is a Phase 1 study of Multiple Myeloma and Immune System Diseases that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 25 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03672318, a Phase 1 study of Multiple Myeloma and Immune System Diseases, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The body has different ways of fighting infection and disease. No single way seems 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 those 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. Both antibodies and T cells have been used to treat subjects with cancers. They both have shown promise, but neither alone has been sufficient to cure most subjects. This study is designed to combine both T cells and antibodies to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD138 antigen (CAR138 T cells). In previous studies, it has been shown that a new gene can be put into T cells that will increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes make up the chemical structure carrying the subject's genetic information that may determine human characteristics (i.e., eye color, height and sex). The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD138. This antibody floats around in the blood and can detect and stick to cancer cells called multiple myeloma cells because they have a substance on the outside of the cells called CD138. Anti-CD138 antibodies have been used to treat people with multiple myeloma, but have not been strong enough to cure most subjects. For this study, the anti-CD138 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. Only the part of the antibody that sticks to the multiple myeloma cells is attached to the T cells instead of the
Conditions Studied
Interventions
- DRUG CAR138 T Cells
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-01-14 |
| Est. Completion | 2039-08-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03672318
The ClinicalTrials.gov registry entry for NCT03672318 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which CAR138 T Cells is the first listed.
NCT03672318 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT03672318 about?
NCT03672318 is a clinical study titled "Study of ATLCAR.CD138 Cells for Relapsed/Refractory Multiple Myeloma". The body has different ways of fighting infection and disease. No single way seems 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 substanc...
What is the current status of trial NCT03672318?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-01-14. Estimated completion is 2039-08-18.
What conditions does trial NCT03672318 study?
This clinical trial studies the following conditions: Multiple Myeloma, Immune System Diseases.
What interventions are being tested in trial NCT03672318?
The interventions under investigation include: CAR138 T Cells (DRUG).
Who is sponsoring clinical trial NCT03672318?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03672318 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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