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NCT04995003 · ClinicalTrials.gov registry record · Phase 1
HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma
A Phase 1 study of Sarcoma and Soft Tissue Sarcoma, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04995003 is a Phase 1 study of Sarcoma and Soft Tissue Sarcoma that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 25 participants, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04995003, a Phase 1 study of Sarcoma and Soft Tissue Sarcoma, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to learn whether it is safe to give HER2-CAR T cells in combination with an immune checkpoint inhibitor drug (pembrolizumab or nivolumab), to learn what the side effects are, and to see whether this therapy might help patients with sarcoma. Another goal of this study is to study the bacteria found in the stool of patients with sarcoma who are being treated with HER2 CAR T cells and immune checkpoint inhibitor drugs to see if the types of bacteria influence how well the treatment works. The investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. They now want to see if they can put a new gene in these cells that will let the T cells recognize and kill sarcoma cells. The new gene that the investigators 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. After this new gene is put into the T cell, the T cell becomes known as a chimeric antigen receptor T cell or CAR T cell. In another clinical study using these CAR T cells targeting HER2 as well as other studies using CAR T cells, investigators found that giving chemotherapy before the T cell infusion can improve 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 the patient's lymphocytes first should allow the infused T cells to expand in the body, and potentially kill cancer cells more effectively. The chemotherapy used for lymphodepletion is a combination of cyclophosphamide and fludarabine. After the patient receives the lymphodepletion chemotherapy and CAR T cells during treatment on the study, they will receive an antibody drug called an immune checkpoint inhibitor, pem
Conditions Studied
Interventions
- DRUG Nivolumab Injectable Product
- GENETIC T cells or CAR T cells
- DRUG Pembrolizumab Injectable Product
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-12-07 |
| Est. Completion | 2043-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04995003
The ClinicalTrials.gov registry entry for NCT04995003 describes a study currently listed as 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 921-participant average among 122 other Sarcoma trials with a reported enrollment target (97% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Sarcoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab Injectable Product is the first listed.
NCT04995003 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04995003 about?
NCT04995003 is a clinical study titled "HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma". The purpose of this study is to learn whether it is safe to give HER2-CAR T cells in combination with an immune checkpoint inhibitor drug (pembrolizumab or nivolumab), to learn what the side effects are, and to see whether this therapy might help patients with sarcoma. Another goal of this study is...
What is the current status of trial NCT04995003?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2021-12-07. Estimated completion is 2043-06-30.
What conditions does trial NCT04995003 study?
This clinical trial studies the following conditions: Sarcoma, Soft Tissue Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Ewing Sarcoma.
What interventions are being tested in trial NCT04995003?
The interventions under investigation include: Nivolumab Injectable Product (DRUG), T cells or CAR T cells (GENETIC), Pembrolizumab Injectable Product (DRUG).
Who is sponsoring clinical trial NCT04995003?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04995003 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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