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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). 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.
Primary Outcome
Will be assessed alone or in combination with dendritic cell-targeting lentiviral vector ID-LV305 (LV305) or in combination with CMB305.
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 |
What the finished NCT03450122 record still lists
NCT03450122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03450122 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03450122's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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