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NCT03450122 · ClinicalTrials.gov registry record · Phase 1
Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03450122: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03450122 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03450122, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This phase I trial studies how well autologous NY-ESO-1-specific CD8-positive T lymphocytes (modified T lymphocytes \[T cells\]), chemotherapy, and aldesleukin with or without dendritic cell-targeting lentiviral vector ID-LV305 (LV305) and immunotherapeutic combination product CMB305 (CMB305) work in treating participants with sarcoma that has spread to other places in the body (advanced) or that has come back (recurrent). Modified T cells used in this study are taken from participants, are changed in a laboratory, and may "kill" some types of tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, 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. Cyclophosphamide may help the body get ready to receive the modified T cells. Interleukins, such as aldesleukin, are proteins made by white blood cells and other cells in the body and may help regulate immune response. LV305 and CMB305 may help stimulate the immune system. Giving modified T cells, chemotherapy, aldesleukin, LV305, and CMB305 may work better in treating participants with sarcoma.
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL Aldesleukin
- BIOLOGICAL Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
- BIOLOGICAL Dendritic Cell-targeting Lentiviral Vector ID-LV305
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-09-13 |
| Est. Completion | 2022-12-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03450122
The ClinicalTrials.gov registry entry for NCT03450122 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03450122 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03450122 about?
NCT03450122 is a clinical study titled "Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma". This phase I trial studies how well autologous NY-ESO-1-specific CD8-positive T lymphocytes (modified T lymphocytes \[T cells\]), chemotherapy, and aldesleukin with or without dendritic cell-targeting lentiviral vector ID-LV305 (LV305) and immunotherapeutic combination product CMB305 (CMB305) work i...
What is the current status of trial NCT03450122?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2018-09-13. Estimated completion is 2022-12-06.
What interventions are being tested in trial NCT03450122?
The interventions under investigation include: Cyclophosphamide (DRUG), Aldesleukin (BIOLOGICAL), Autologous NY-ESO-1-specific CD8-positive T Lymphocytes (BIOLOGICAL), Dendritic Cell-targeting Lentiviral Vector ID-LV305 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03450122?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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