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NCT05989828 · ClinicalTrials.gov registry record · Phase 1
A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer
A Phase 1 study, sponsored by University of Southern California.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT05989828 is a Phase 1 study that is actively recruiting participants, run by University of Southern California. The registered enrollment target is 20 participants.
The verdict
NCT05989828, a Phase 1 study, is actively recruiting participants, sponsored by University of Southern California.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase Ib trial tests the safety, side effects and best dose of anti-HLA-A2/NY-ESO-1 T-cell receptor (TCR)-transduced autologous T lymphocytes (A2-ESO-1 TCR-T cells) in treating patients with NY-ESO-1 overexpression positive triple negative breast cancer (TNBC) that has come back after a period of improvement (relapsed/recurrent) or that does not respond to treatment (refractory), and that may have spread from where it first started (primary site) to nearby tissue, lymph nodes (advanced) or to other places in the body (metastatic). NY-ESO-1 is an antigen found on the surface of many different types of tumor cells including TNBC. Antigens make it possible for immune cells to recognize and kill germ cells that invade the body, however, it is more difficult for immune cells to recognize antigens on tumor cells. T cells are a special type of immune cell in the blood. These T cells may be trained to recognize the NY-ESO-1 antigen on tumor cells, allowing the T cells to attack and kill those tumor cells. The A2-ESO-1 TCR-T cells are T cells that have been removed from the patient's blood through a process called leukapheresis and then changed in the laboratory to recognize NY-ESO-1 on tumor cells. When given back to the patient, these A2-ESO-1 TCR-T cells find and attack tumor cells that express NY-ESO-1. Chemotherapy drugs, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. They are given before the T cells to support optimum activity of the A2-ESO-1 TCR-T cells. IL-2 (aldesleukin) is in a class of drugs known as cytokines. It is a man-made version of a naturally occurring protein that stimulates the body to produce other chemicals which increase the body's ability to fight cancer. A2-ESO-1 TCR-T cells may kill more tumor cells in patients with recurrent or refractory advanced or metastatic TNBC that overexpresses NY-ESO-1.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- BIOLOGICAL Aldesleukin
- BIOLOGICAL Anti-HLA-A2/NY-ESO-1 TCR-transduced Autologous T Lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-12-17 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05989828
The ClinicalTrials.gov registry entry for NCT05989828 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05989828 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05989828 about?
NCT05989828 is a clinical study titled "A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer". This phase Ib trial tests the safety, side effects and best dose of anti-HLA-A2/NY-ESO-1 T-cell receptor (TCR)-transduced autologous T lymphocytes (A2-ESO-1 TCR-T cells) in treating patients with NY-ESO-1 overexpression positive triple negative breast cancer (TNBC) that has come back after a period ...
What is the current status of trial NCT05989828?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-12-17. Estimated completion is 2028-12-31.
What interventions are being tested in trial NCT05989828?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Aldesleukin (BIOLOGICAL), Anti-HLA-A2/NY-ESO-1 TCR-transduced Autologous T Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT05989828?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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