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NCT03721068 · ClinicalTrials.gov registry record · Phase 1

Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

A Phase 1 study of Neuroblastoma and Osteosarcoma, sponsored by UNC Lineberger Comprehensive Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
18
Enrollment target
2
Study locations

NCT03721068 is a Phase 1 study of Neuroblastoma and Osteosarcoma that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 18 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03721068, a Phase 1 study of Neuroblastoma and Osteosarcoma, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
18 participants
Enrollment target
2
Study locations

Study Summary

The body has different ways of fighting infections 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 molecules that fight infections and protect your body from diseases caused by bacteria and toxic substances. Antibodies work by sticking to those bacteria or substances, which stops them from growing and causing bad effects. T cells 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 patients with cancers. They both have shown promise, but neither alone has been enough to cure most patients. This multicenter study is designed to combine both T cells and antibodies in order to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells (CAR) cells targeted against the disialoganglioside (GD2) antigen that express Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9), also known as iC9.GD2.CAR.IL-15 T cells.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • BIOLOGICAL iC9.GD2.CAR.IL-15 T-cells

Study Locations (2)

Georgia

  • Emory - Winship Cancer Institute - Atlanta

North Carolina

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2019-02-19
Est. Completion 2044-06-19
Phase Phase 1

What the Registry Record Tells You About NCT03721068

The ClinicalTrials.gov registry entry for NCT03721068 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% 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 Neuroblastoma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.

NCT03721068 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Georgia, North Carolina.

Frequently Asked Questions

What is clinical trial NCT03721068 about?

NCT03721068 is a clinical study titled "Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma". The body has different ways of fighting infections 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 molecules that fight infections and protect your body from diseases caused by b...

What is the current status of trial NCT03721068?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-02-19. Estimated completion is 2044-06-19.

What conditions does trial NCT03721068 study?

This clinical trial studies the following conditions: Neuroblastoma, Osteosarcoma.

What interventions are being tested in trial NCT03721068?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), iC9.GD2.CAR.IL-15 T-cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT03721068?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03721068 being conducted?

This trial has 2 study locations across Georgia, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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