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NCT00902044 · ClinicalTrials.gov registry record · Phase 1

Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma

A Phase 1 study of Sarcoma, sponsored by Baylor College of Medicine.

Active
Registry status
Phase 1
Development phase
36
Enrollment target
2
Study locations

NCT00902044 is a Phase 1 study of Sarcoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 36 participants, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT00902044, a Phase 1 study of Sarcoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
2
Study locations

Study Summary

Patients have a type of cancer called sarcoma. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from diseases caused by germs or toxic substances. They work by binding those germs or substances, which stops them from growing or exerting their toxic 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 germs. Both antibodies and T cells have been used to treat patients with cancers: they both have shown promise, but have not been strong enough to cure most patients. We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. We now want to see if we can put a new gene in these cells that will let the T cells recognize and kill sarcoma cells. The new gene that we will put in makes an antibody specific for HER2 (Human Epidermal Growth Factor Receptor 2) that binds to sarcoma cells. In addition it contains CD28, which stimulated T cells and make them last longer. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. Giving chemotherapy before a T cell infusion is called lymphodepletion since the chemotherapy is specifically chosen to decrease the number of lymphocytes in the body. Decreasing the number of patient's lymphocytes first should allow the T cells we infuse to expand and stay longer in your body, and potentially kill cancer cells more effectively. We will use f

Conditions Studied

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • GENETIC Autologous HER2-specific T cells
  • GENETIC Autologous CAR Positive T cells

Study Locations (2)

Texas

  • Houston Methodist Hospital - Houston
  • Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2010-02-11
Est. Completion 2032-07
Phase Phase 1

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT00902044

The ClinicalTrials.gov registry entry for NCT00902044 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (96% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sarcoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT00902044 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00902044 about?

NCT00902044 is a clinical study titled "Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma". Patients have a type of cancer called sarcoma. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immun...

What is the current status of trial NCT00902044?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2010-02-11. Estimated completion is 2032-07.

What conditions does trial NCT00902044 study?

This clinical trial studies the following conditions: Sarcoma.

What interventions are being tested in trial NCT00902044?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Autologous HER2-specific T cells (GENETIC), Autologous CAR Positive T cells (GENETIC).

Who is sponsoring clinical trial NCT00902044?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00902044 being conducted?

This trial has 2 study locations across Texas. 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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